Strategic Plan Environmental Assessment - NIH Clinical … · Strategic Plan Environmental Assessment ... and fiscal manage- ... • The new building has also served as a stimulus

Warren Grant Magnuson Clinical Center

National Institutes of Health

2001

Strategic Plan

Environmental Assessment

This file is provided for reference purposes only. It was current when it was produced, but it is no longer maintained and may now be out of date. Persons with disabilities having difficulty accessing information may contact us for assistance (www.cc.nih.gov/contact.shtml). For reliable, current information on this and other health topics, we recommend consulting the NIH Clinical Center at http://www.cc.nih.gov/.

Contents 1

Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Clinical Center Strengths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Clinical Center Weaknesses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Factors in the External and Internal Environments Influencing Change

in Healthcare Delivery and Clinical Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Societal & Value-Based Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Population & Clinical Research Subject-Based External Factors . . . . . . . . . . . . . . . . . . . . . 19

Cost-Based External Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Medical Practice-Based External Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Government-Based External Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Agency (NIH)-Based External Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Table of Contents

The Warren Grant Magnuson Clinical Center(CC), National Institutes of Health, United StatesDepartment of Health and Human Services(DHHS) faces substantial challenges and opportu-nities as it moves into the 21st century. In 1996 inresponse to concerns about the rising costs of con-ducting clinical research at the CC, the DHHSSecretary commissioned an external review of CCoperations. To determine the CC’s optimal operat-ing structure, a review group (that came to beknown as the “Options Team”) visited cutting-edgeacademic, non-academic, public, private, and feder-al healthcare institutions throughout the UnitedStates. One of the major recommendations resultingfrom the review effort was for the CC to engage instrategic planning, and, as part of that activity, con-duct a thorough environmental assessment to deter-mine CC strengths, weaknesses, opportunities, andthreats. This document represents the fourth editionof the CC’s Strategic Plan EnvironmentalAssessment. The CC has five years of experience inthe use, evaluation, and modification of its strategicplan. In that time factors influencing the CC envi-ronment have continued to change. This documentsummarizes interventions that have been taken toaddress weaknesses and bolster strengths; identifieschanges that have occurred; and provides additionalcommentary within the context of the original envi-ronmental assessment.

The CC has numerous strengths, among them:

1. The CC is the clinical research arm of one of thestrongest, most visible scientific programs in theworld – the intramural program at the NationalInstitutes of Health;

2. The CC has a critical mass of world class scien-tists and clinical investigators working closelytogether to develop and conduct translationalclinical research;

3. The CC support staff and research infrastructureare uniquely tailored to support excellence inclinical research;

4. The CC focuses on a unique research portfoliothat would be difficult, if not impossible, to con-duct at other venues;

5. The CC staff are capable of providing, and haveconsistently provided, the highest quality patientcare to clinical research subjects;

6. Unlike patient-care-oriented academic medicalcenters, the CC culture is science-driven;

7. Because of its unique clinical research mission,the CC has an organizational and scientific flex-ibility that most institutions do not possess; and

8. The CC provides investigators access to expen-sive, state-of-the-art technologies that are notreadily available in many other venues.

These strengths, identified in the initial version ofthis document, remain evident after five years ofexperience with the strategic plan.

Self-evaluation, during preparation of the first edi-tion of this document, also identified several orga-nizational weaknesses at the CC, among them:

1. Existing CC governance mechanisms wereunclear;

2. The CC was subject to bureaucratic inflexibilityin personnel, procurement, and fiscal manage-ment;

3. The CC’s physical plant urgently needed renewal;

4. The CC lacked a strategic plan;

5. CC information systems did not adequately sup-port managerial and financial data and did notintegrate clinical, research, managerial and finan-cial data;

Executive Summary 3

Executive Summary

6. CC successes were not adequately communicat-ed to the public, to referring physicians, and tothe insurance and managed care industries;

7. CC patient recruitment efforts were increasinglyless successful; and

8. The fact that the CC does not offer complete,integrated medical and surgical services may bean institutional weakness.

Progress in Addressing Identified Weaknesses

During the past five years, many of the weaknessesidentified in the initial environmental assessmenthave been addressed. The establishment of theBoard of Governors clarified the CC governancestructure; however, to make certain that the CC’smajor stakeholders have an opportunity to con-tribute to the governance, the NIH Director hassubsequently created additional advisory panels. Inthe past two years the CC’s governance has contin-ued to evolve. The DHHS Secretary removed manyof the bureaucratic impediments inherent in certainofficial government processes. A new ClinicalResearch Center is being built. Markedly improvedfinancial information (e.g., activity-based costingdata) is now readily available to CC and NIHInstitute/Center (IC) staff, and a highly successfulPatient Recruitment and Public Liaison Service hasbeen established. These changes and their impactare discussed in detail in this Strategic PlanEnvironmental Assessment update.

Weaknesses Identified Since 1996

In the interim period since this document’s first edi-tion, several additional potential weaknesses havebeen identified, specifically:

1. Communication practices are inconsistent acrossthe CC and the NIH;

2. The CC has not routinely sought customerinput about its services;

3. CC customer service needs improvement;

4. The CC has substantial opportunities to increaseits attention to workforce diversity and health-care disparities; and

5. The CC has difficulty reconciling competing ICdemands within a defined budget and has noclear-cut mechanisms for making decisions thatbenefit the entire organization (as opposed toindividual customers).

Opportunities and Threats

The CC has also evaluated opportunities andthreats presenting themselves as a result of changesin its internal and external environments. Most ofthe factors identified as change agents remain pres-ent in the CC’s current environment. Among theinternal and external environmental factors initiallyidentified as influencing change in healthcare deliv-ery and clinical research are:

1. The sociopolitical climate, potential for increasedacts of terrorism, and declining economy willadd a degree of instability to the NIH environ-ment in the next few years.

2. Societal values are changing and bearing influ-ence on healthcare and clinical research. Societyrelies increasingly on technology and its advances,including those in medicine and biomedicalresearch, to provide what has become an expect-ed level of health, function, and longevity.

3. The U.S. population and its interests and knowl-edge base are changing rapidly: patients and clin-ical research subjects are becoming increasinglysophisticated healthcare consumers; science edu-cation in the U.S. is not keeping pace with therest of the world and the U.S. population isbecoming less “science-literate;” societal demo-graphics are changing; society has becomeincreasingly litigious; and interest in “alternativeand complementary” medicine is increasing.

4. Cost continues to be a primary consideration inhealthcare delivery and clinical research. Clinicalresearch is intrinsically expensive and healthcareinflation is high. The net effect is that cost con-tainment in the CC environment is difficult.

5. Medicine, the practice of medicine, and the con-duct of clinical research are changing rapidly.Science is becoming increasingly collaborative,and progress in biomedical research producesnatural change in the research agenda. Allhealthcare institutions are being asked to meas-ure performance and to demonstrate perform-ance improvement. Patient safety and human

4 Strategic Plan Environmental Assessment

subjects protection have become increasinglyimportant. Nationwide a shortage of nurses,pharmacists, and medical and radiological tech-nical staff remains a continuing problem.

6. Changes in governmental regulatory require-ments and governmental oversight are drivingchange in medical practice and clinical research.In FY 2001, the President reiterated an interestin downsizing and outsourcing while issuing fivemajor goals for reforming governmental man-agement practices, including goals relating to:

• Budget and Performance Integration

• Strategic Management of Human Capital

• Competitive Sourcing

• Improving Financial Performance

• Expanding Electronic Government

Each of these goals is discussed in more detail in the text.

7. Changes at NIH are also influencing the mannerin which the CC operates.

• To address the needs of the CC’s failing physicalplant, a new Clinical Research Center is underconstruction and projected to open in 2004.

• The organization and administration of patientcare in the new facility will be different fromexisting mechanisms. The new building and thechange in clinical and administrative governancein patient care presents the CC with a uniqueopportunity to reassess the processes used to pro-vide care and affords an opportunity to redesignsome of these processes for improvement inpatient care quality and/or efficiency.

• The new building has also served as a stimulusfor the ICs to improve and expand their clinicalresearch programs. Several ICs have initiatednew programs and/or recruited new clinicalinvestigators to buttress their clinical researchactivities. These substantial program modifica-tions and expansions require the careful assess-ment of CC administrators and departmentmanagers.

• Several ICs have developed new initiatives thatinvolve ‘off-site’ activities, and have requestedCC support for these activities. These programsrange from underserved communities’ outreachefforts to telemedicine projects. The CC mustdevelop strategies to address the many significantregulatory, economic, and logistical issues arisingfrom these initiatives in order to maintain thehighest possible care standards for the services itprovides.

• As technology advances, the ICs increasinglyrequest more and more sophisticated and, there-fore, expensive clinical-research support.

• To address another perceived organizationalweakness the CC is renovating its medical infor-mation system, again requiring careful assessmentof the processes of care, with the intent of mov-ing toward a completely electronic medicalrecord. The new information system will also givethe organization an opportunity to develop betterdepartmental, financial, and back-end (i.e., IC)clinical-research support than the existing system.

• The past several years have seen a doubling of theNIH budget. This doubling will be complete in2003 and NIH is preparing for leaner budgets insubsequent years (the so-called ‘soft landing’).The fact that certain hospital costs will likelycontinue to escalate at a rate far exceeding intra-mural budget growth demands cost conscious-ness and creativity from CC managers.

Thus, during the past five years a combination offactors has resulted in a substantial cultural changein the NIH intramural community. These factorsand the resulting change in the internal CC envi-ronment are enumerated in this document.

This report assesses these opportunities and threatsin detail in the context of the identified strengthsand weaknesses inherent in the CC.

Executive Summary 5

The CC finds itself poised for dramatic changein an increasingly complex healthcare environment.A clear understanding of this complicated environ-ment, including a detailed assessment of the organi-zation’s strengths, weaknesses, and opportunities,and factors from the internal and external environ-ments that threaten the organization is essential forthe CC to prevail in the next decade and beyond.To succeed, the CC must identify its internalstrengths and capabilities and position itself to meetthe challenges posed by ongoing changes inAmerican healthcare delivery systems and industry.

In 1995, the CC was provided with a unique oppor-tunity to conduct a thorough environmental assess-ment as a result of a mandate from former DHHSSecretary Donna Shalala that the CC undergo adetailed external review of its operations. Dr. HelenSmits, former Deputy Administrator for the HealthCare Financing Administration (HCFA), led theOptions Team that conducted this review. Thisreview ultimately provided the CC with an oppor-tunity to study the best practices of 30 facilitiesthroughout the country, with an eye toward adopt-ing many of these best practices at the CC.1 In theintervening 60 months since this document was firstwritten, the CC has sought additional input from:1) its major customers, the NIH ICs (through theClinical Center Research Steering Committee, for-merly the Clinical Center Advisory Council), theClinical Research Revitalization Committee, theFunding Advisory Review Board, and the Clinical,Scientific, and Institute Directors; 2) the extramuralacademic community (through ongoing reviews bythe Clinical Center Board of Scientific Counselors);and through separate meetings convened with out-side experts to chart the future courses of the CC’sBioethics Program, Imaging Sciences Program,Laboratory Medicine Department, and the Painand Palliative Care Service; 3) industry, insurers,and managed care representatives (in two meetingsdesigned to address patient recruitment and thirdparty payment issues); 4) healthcare executives andexperienced healthcare administrators (through

meetings of the CC’s Board of Governors); and 5)intramural and extramural experts in hospital oper-ations, in the conduct of operational reviews of CCdepartments. The advice and counsel of these intra-mural and extramural advisors provide the backbonefor the CC’s current environmental assessment.

The CC’s 2001 Strategic Plan EnvironmentalAssessment is divided into three segments: 1) CCstrengths; 2) CC organizational weaknesses; and 3)external trends and factors influencing change: a) inhealthcare; b) in clinical research, in general; and c) in clinical research at the CC, including anemphasis on opportunities that present themselvesto the CC in the context of these other findings.

Introduction 7

Introduction

The CC serves as the clinical research arm,and an integral component of, the NIH biomedicalresearch community. As a national resource, the CCprovides the patient care, services, and environmentneeded to initiate and support the highest quality,conduct of, and training in, clinical research. TheCC provides a unique venue and opportunity inwhich to conduct studies that bridge the gapbetween basic science and clinical application at thepatient’s bedside. In 1994, a panel of extramural sci-ence advisors convened at the request of the NIHDirector to assess the status of the intramuralresearch program noted that the CC has been, “...aunique and invaluable resource for the direct clini-cal application of new knowledge derived from basicresearch.” In the conclusion of their report, theseexternal advisors noted,

“Upon analysis of the programs of the Clinical Centerfacility, the External Advisory Committee is strongly ofthe opinion that the Clinical Center is essential to theintramural research program. The committee recog-nizes that a crucial asset of the Clinical Center complexis the flexibility it offers to respond to new opportuni-ties and needs by rapid redirection of resources, such aswith research on human immunodeficiency virus,breast cancer, and prostate cancer. Because the ClinicalCenter is not obligated to provide all types of clinicalservices, it can more readily redirect resources to new,innovative areas of research. In addition, the existenceof a high caliber staff, on-site, with expertise in clini-cal research, allows for the rapid implementation ofnew initiatives.2

The Committee also recognizes that the ClinicalCenter, with its appropriate facilities and support staff,allows scientists to conduct long-term clinical studies ofindividual patients and large families that would bedifficult, if not impossible, to do in the extramuralcommunity because of the lack of sufficient and long-term funding. It also provides an excellent setting forthe training of clinical investigators.” 3

In the late 1990s the NIH leadership invested heav-ily in the revitalization of the Clinical Center.4 Thisrevitalization has helped position the CC to meetthe expanding clinical research agendas of the ICsfor the foreseeable future.

In the 48 years since the CC opened its doors to thepublic, the CC and its staff have contributed signif-icantly to biomedical science and translationalresearch – moving discoveries in the basic sciencesinto clinical medicine. In the process of providingthe infrastructure and research support for IC scien-tists during this period, the CC and its staff havedeveloped many unique organizational strengths.Among them are the following:

• The CC is the clinical research arm of the

intramural program of the NIH.

The NIH is among the most respected scientificorganizations in the world. Its intramural programhas received consistent intellectual and scientificsupport from the academic scientific community aswell as steady economic support from the U.S. gov-ernment. As the clinical research arm of the intra-mural component of the NIH, the CC is not sub-ject to the extremes of funding crises prevalent inthe extramural community. For this reason sometypes of studies, particularly those relating to natu-ral history and disease pathogenesis, as well as stud-ies of orphan diseases, can be conducted almostnowhere else but, and nowhere as well as, at the CC.

• The CC has a critical mass of world-class

scientists and clinical investigators working

closely together.

Perhaps no other center in the world has the collabo-rative mix of basic scientists and clinical researchersfound in the NIH intramural program. This blendof basic and clinical science has provided a criticalmass of scientific ferment that has produced strikingaccomplishments in clinical research during the first48 years of the CC’s existence. The fact that the basic


Clinical Center Strengths

and clinical scientists work in close proximity pro-duces a cross-fertilization of ideas that is unique in theacademic medical community. The quality of thebasic and clinical scientists cannot be overempha-sized; many of the NIH intramural investigators arerecognized as international authorities in their fields.

• The support staff and research infrastructure in

the CC are uniquely tailored to support excel-

lence in clinical research.

Unlike most academic medical centers, CC supportstaff and service personnel have been recruited tosupport a clinical research, rather than a purelypatient care, mission. The service and support staffsat the CC provide unrivaled support for clinicalresearch. The CC staff also provides state-of-the-artclinical diagnostic support services. Support staffand service personnel often function as collabora-tors in research studies and have made numeroussubstantive scientific contributions. At all levels ofthe organization, completion of the research mis-sion is a highly visible goal.

• The CC focuses on a unique research portfolio.

As noted above, unlike most academic medical cen-ters, studies conducted at the CC much more fre-quently evaluate the natural history or pathogenesisof disease states. Clinical trials at the CC are prima-rily Phase I and Phase II trials, as compared withmost extramural centers, which focus primarily onPhase III and Phase IV studies. The CC offers asuperb venue in which to conduct translational or‘proof of concept’ studies. Additionally, scientistsworking at the CC have assembled cohorts ofpatients who have rare or orphan diseases. Forpatients who have certain orphan diseases, the CCmay be the only place where meaningful clinicalresearch studies of their conditions are carried out.The study of rare and orphan diseases has resultedin innumerable contributions to the understandingof basic human physiology, pathology, psychology,genetics, and immunology.

• The CC provides the highest quality patient

care to its clinical research subjects.

The CC’s staff is committed to the clinical researchmission. To provide optimal support for clinical sci-ence, the CC’s highly skilled service and supportstaffs have consistently provided excellent care to thesubjects of clinical research protocols. The subjectsof clinical research studies have a different relation-

ship to the CC than the relationship patients havewith a typical academic medical center to whichthey are admitted. The subjects of these studies arepartners in the research carried out at the CC. Forthis reason, the importance of providing excellencein patient care cannot be overemphasized.Excellence in patient care remains a major objectivefor the CC staff, an objective that has been reachedconsistently during its first four decades of exis-tence, and a goal toward which CC administrationand staff continuously strive. Excellence in patientcare is an ever-moving target.

• The culture of the CC is science-driven.

The principles of performance improvement arebased on the principles of epidemiology. The cul-ture and mission of the CC are grounded entirely inscience. CC scientists and managers are familiarwith the epidemiological orientation of perform-ance improvement. Scientists and staff are accus-tomed to using epidemiological principles to ana-lyze data and to make decisions. For this reason,CC staff are well positioned to collect and analyzemanagerial data and to integrate the results of dataanalysis into decisions affecting the manner inwhich the work of the organization is conducted.The entire organization has been trained in the epi-demiological principles of performance improve-ment and both managers and line employees usethese principles. The science-based culture of theCC positions it extremely well to use these princi-ples scientifically to: 1) collect data for performancemeasurement; 2) analyze the data to address identi-fied problems; 3) propose interventions based onsolid, scientifically obtained data; and 4) assess theusefulness of these interventions.

In the intervening 60 months since the first editionof this document many of the ICs have initiatedmajor external reviews of their intramural clinicalprograms. The Director’s Clinical Research Panelhas also underscored the importance of quality clin-ical research. These and other initiatives suggestthat, across the campus, interest in quality clinicalresearch is increasing. In addition, the planning ofthe new Clinical Research Center, the increasedemphasis on cross-disciplinary molecular projects,and the changing intramural environment havespawned a new level of collaboration and customer-orientation among CC leadership.

Clinical Center Strengths 9

• Because of its unique clinical research mission,

the CC has organizational and scientific flexi-

bility that most institutions do not have.

Because the primary mission of the CC is clinicalresearch, the institution does not make commit-ments, either to its research subjects or to the com-munity, to provide comprehensive healthcare servic-es. Because the CC does not have to commitresources and personnel to an Emergency Room orgeneral acute care, it can focus its efforts on specificareas of clinical science. For this reason the IC-driv-en science conducted in the CC can respond quick-ly, both to emerging problems for which an imme-diate change in the national research agenda is need-ed, as well as to scientific opportunities when theyarise. For example, the CC responded quickly tostudy: 1) AIDS and HIV infection when the diseasefirst surfaced in society; 2) multiple-drug-resistanttuberculosis when the problem first became appar-ent; 3) chemotherapy for ovarian cancer when Taxolbecame available; and 4) solid organ transplantationprogram when innovative transplantationapproaches were developed.

• The CC provides access to expensive state-of-

the-art technologies that are not readily avail-

able in many other centers.

Since the CC and the NIH intramural programs arecharged with advancing the frontiers of science, theCC often either develops, or is among the first toacquire, new technologies that facilitate the conduct ofclinical research. Scientists working at the CC haveaccess to numerous molecular techniques, PositronEmission Tomography (PET) scanners, threecyclotrons, several Magnetic Resonance Imaging(MRI) machines (including the 3, 4, and 7 Teslaexperimental machines), unique cell-processing facili-ties, and a variety of other cutting-edge technologies.


As a result of dual evaluations, one by externaladvisors as well as self-assessment exercises, the CCinitially identified several issues that might be con-sidered programmatic or systemic weaknesses.

• Existing CC governance mechanisms are

unclear.

Historically, governance of the CC was unclear,with multiple committees providing oversight. Theold structure lacked clarity in how decisions weremade. The net effect of the indistinct lines ofauthority is that the CC lacked the means to man-age its business efficiently.

In the past 60 months, the NIH has continued towrestle with the development of clear, effective gov-ernance for the CC. In 1996, the CC appointed andconvened a new Board of Governors. The Board ofGovernors developed and approved a streamlinedorganizational reporting system for the CC. As aresult of the introduction of this new governancesystem, IC stakeholders felt somewhat disenfran-chised and appealed to the NIH Director. A newadvisory board, initially called the Clinical CenterAdvisory Council, was then appointed by the NIHDirector that permitted the major stakeholders toaddress CC issues that are important to the ICs andto provide advice and counsel to the Director of theClinical Center. This council has recently beenreconstituted by the NIH Acting Director as theClinical Center Research Steering Committee(CCRSC). The CCRSC continues to provide avenue in which the ICs can contribute to the gover-nance of the CC. An additional advisory group, theFunding Advisory Review Board (FARB), has alsobeen constituted by the NIH Acting Director torecommend to the Acting Director through the ICdirectors funding levels for centralized services onthe campus (including the CC). In the past threeyears, the CC Director has sought advice fromanother important stakeholder – CC patients. TheCC Director created a Patient Advisory Group thathas provided and continues to provide advice to the

Director from the perspective of clinical researchparticipants. The governance structure for the CCremains complex, however, the relative roles each ofthese new (as well as the older, existing) advisorygroups play in the governance of the CC are beingclarified.

• The CC is subject to bureaucratic inflexibility in

personnel, procurement, and fiscal manage-

ment, especially in the existing budget process,

which is confusing and frustrating.

As a center in the NIH (agency), the CC reports tothe agency, the Public Health Service (PHS), andthe Department of Health and Human Services. Itsactivities are subject to agency rules, regulations,and policies; PHS rules, regulations, and policies;DHHS rules, regulations, and policies; rules, regu-lations, and policies of the Office of Managementand Budget, the Office of Personnel Management,the General Services Administration; and all otherapplicable Federal rules, regulations, and policies, aswell as applicable Federal statutes. According to theDHHS Options Team report, as a result of thisextensive bureaucracy, “The Clinical Center faces aseries of very serious barriers to managerial efficien-cy in areas such as personnel, purchasing, and con-tracting….5 The Clinical Center needs a great dealof flexibility to operate productively.”6 With respectto procurement, the report states, “The ClinicalCenter’s procurement system is time-consuming,labor-intense, costly, and slow to change.”7 Withrespect to personnel systems, the report states, “Thegovernment’s personnel system is so complex thatmanagers and employees find it difficult to under-stand. It is so fragmented that they have difficultymaking the system support their needs. Althoughthe government’s personnel system is structured toprovide fair, consistent rules for employees andmanagers, it undermines the Clinical Center’s effi-cient operation.”8 With respect to fiscal issues, thereport states, “As is the case with all governmentoperations, the Clinical Center must spend its entirebudget within the fiscal year; no carryover is allowed

Clinical Center Weaknesses 11

Clinical Center Weaknesses

9...the Clinical Center should have a means ofretaining reserves from year to year.”10 The reportalso notes that the NIH’s existing budget process forthe Clinical Center “...makes future Clinical Centerfunding far more unstable than funding of NIH asa whole.” 11 Finally, external reviewers suggested thatthe Clinical Center did not have an effective cost-accounting system that provided “timely informa-tion about performance and cost.”12

Since the first edition of this document was written,the CC has worked with the NIH Director and theDirectors of the ICs in an effort to streamline theCC’s funding stream. The old funding mechanismrewarded “non-use” of the CC. A new fundingmechanism has been designed, patterned after theconcept of a “school-tax.” Because IC charges arenot linked to use in this new system, it should stim-ulate use of the CC and will provide far more stablefunding than the old funding mechanism. This newmechanism was put in place in the FY 2000 budgetcycle. Appropriations language was written for theFY 1997 budget cycle to allow the CC to carry oversome funds; this language has again been approvedfor the present fiscal year. These carryover fundsprovide an important source of revenue support fornew clinical research initiatives of the ICs. The CChas also attempted to address the issue of inadequatecost accounting. The CC hired a consultant to pro-vide advice about the establishment of a cost-accounting system. The recommendations of theconsultant have been adopted and the CC is imple-menting the new system. This new activity-basedcosting system should be of substantial utility to theCC’s major customers and stakeholders.

Performance measurement continued as a majororganizational focus in 2001. During the past threeyears the CC has collected organization-wide activ-ity data that are used by the Director to assess over-all performance. In addition, CC departments col-lect data relevant to the performance of their indi-vidual operations. The goal of measuring perform-ance is to track departmental and organizationalprogress toward our strategic goals. Thus, an impor-tant aspect of the performance measurement systemis making certain that the outcomes and processesbeing measured are relevant to our key initiativesand strategic goals and that the measurement ofthese structures, processes, and outcomes allow us totrack progress toward these organizational goals.The performance measurement initiative is relevantto both the operations of the CC as well as to clini-cal care provided in our facility.

In the years since the initial draft of this documentwas written, NIH has also received several delega-tions of authority from the DHHS Secretary. Use ofthese delegations has already begun to address someof the problems relating to inflexibility in personneland procurement systems.

During the past two years the CC’s Office ofHuman Resources Management has developed (andhad approved by the DHHS Secretary) a pilot pro-gram to be able to use a new personnel authority,Title 42, to appoint clinical research support staff.This project – novel in the government – is under-way. Initial performance measurement activitiesrelated to implementation of the project suggest anincrease in efficiency of responsiveness anddecreased vacancy rates in relevant departments.

• Many intramural and extramural authorities

believe that clinical research is relatively under-

valued.

Clinical researchers nationwide have long held theperception that NIH relatively undervalued theirwork. In 1979, then NIH Director JamesWyngaarden, referred to the clinical researcher as an“endangered species.” In response to the concerns ofboth intramural and extramural scientists concern-ing the standing of clinical research, Dr. HaroldVarmus, Director, NIH convened a blue-ribbonpanel of experts (the Clinical Research Panel) thatwas charged with reviewing the status of clinicalresearch in the U.S. and making recommendationsto the NIH Director on how that office mightensure effective continuance of clinical research inthe U.S. Dr. David Nathan, president of the DanaFarber Cancer Institute, chaired the committee. Thecommittee made ten formal recommendations,which can be summarized as follows:

• NIH should monitor and track resources committed to clinical research.

• NIH should ensure fair and effective reviews ofclinical research grant applications.

• NIH should initiate programs that enhance theattractiveness of careers in clinical research tomedical students.

• NIH should ensure the quality of training forclinical researchers by careful mentoring and byrequiring formal training in clinical research.


• NIH should initiate new support mechanismsfor young and mid-career clinical investigators.

• NIH should increase the scope of, and fundingfor, General Clinical Research Centers.

• NIH should continue to improve the quality ofclinical research and strengthen clinical researchmanagement at the CC and make its resourcesavailable to extramural investigators.

• NIH should enter and sustain a dialogue onenhancing clinical research with academic cen-ters, private foundations, pharmaceutical man-ufacturers, and managed care organizations.

• NIH should expand efforts to educate the pub-lic about the importance of clinical research.

The leadership of the NIH and of the CC took theserecommendations seriously and developed substan-tive responses to many of them. An introductorycourse on the principles and practice of clinicalresearch has trained 2,000 students and an accompa-nying textbook for the course has been written. AClinical Research Training Program for medical stu-dents, including mentoring by some of NIH’s mostaccomplished clinical researchers has already beensuccessfully implemented. Two collaborative Masters’Degree programs in clinical research have been devel-oped with Duke University and the University ofPittsburgh. A required course on clinical research forall principal investigators has been established and isnow available on the World Wide Web. A clinicalpharmacology course has been developed and imple-mented (complete with a newly published textbook)and a Bioethics Course has been developed andimplemented. Intramural programs have reviewedand revitalized their clinical programs. Both NIHand the CC have begun dialogues with the insuranceand managed care industry. These activities aredescribed in detail elsewhere in this document.

• The CC’s physical plant urgently needs renewal.

“The Clinical Center’s 48-year-old physical plant is increasingly inadequate for the conduct ofclinical research; it requires replacement.”13

A Congressionally-mandated external review of theNIH intramural program conducted by an advisorycommittee to the NIH Director’s AdvisoryCommittee also concluded, “In recent years, it hasbecome clear that the infrastructure of the ClinicalCenter is deteriorating14...The External Advisory

Committee agrees with the need for renewal of theClinical Center.”15

NIH, DHHS, and Congress approved the conceptof building a new Clinical Research Center, anarchitect was selected, a private developer hired, andconstruction is progressing. Congress has now pro-vided funding for the total construction project. Toincrease customer input in the design process, teamsof partners (i.e., IC staff, CC staff, and patients thatwill share space and resources in the new building)have been convened to assist in the design process.The CC and its IC partners are aggressively plan-ning for the transition from Building 10 into thenew facility.

• The CC lacked a strategic plan in 1995.

Although a strategic plan was drafted in 1990, thisplan was never implemented. The plan was neverused for conjoint planning with the ICs, nor was itused to facilitate decision-making. One externalreview stated, “The Clinical Center lacks a strategicplan describing how it will respond to long-rangeInstitute needs, extramural pressures to reduce costs,and competition to alternatives to intramuralresearch. Without such a plan, decisions that havelong-lasting consequences or require long lead-times, will be untimely, if they are made at all.”16

After obtaining input from major internal (e.g., CCDepartment Heads) and external (e.g., ICDirectors, IC Scientific and Clinical Directors) cus-tomers, the CC developed a strategic plan. The planwas presented to, and approved by, the ClinicalCenter Board of Governors. This strategic plan hasbeen in place and functioning well as a template forprogress during the past 60 months. The strategicplan is revised annually to make certain it accurate-ly reflects our direction and is responsive to theneeds of our customers and stakeholders. The CCviews it’s strategic plan as a dynamic document –projects are continuously being evaluated, revisedand improved.

In addition, within the past year the CC has draftedits first annual operating plan for FY2000; this processwas refined in FY2001; and an FY2002 plan is underdevelopment. These documents delineate organiza-tional priorities for the upcoming fiscal year, providealignment of the short-term organizational prioritieswith long-term goals, provide a structure to help indecision-making during the fiscal year, and provide anew framework for managerial accountability.


• CC Information Systems do not adequately

support managerial and financial data.

The CC has long been a world leader in the field of“computerizing clinical data;”17 however, theClinical Center’s information systems fall short inproviding managerial and financial data required byIC and Clinical Center managers. One set of exter-nal consultants concluded that “...the data providedare retrospective and difficult to use in operationaldecisions.... The architecture of the computer sys-tem is outmoded and cannot effectively integratedata between and among departments.”18

In the past 60 months, several projects have beeninitiated to improve the quality and availability offinancial and resource utilization information forbetter management of CC operations. The CCrecruited its first Chief Financial Officer who nowprovides overall direction for financial and resourceutilization, setting the standards and defining therequirements. In June, 1999 a new ChiefInformation Officer was appointed.

In the past year, the CC has reorganized itsInformation Systems staff to include two depart-ments – the Department of Network Applications(DNA) and the Department of Clinical ResearchInformatics (DCRI). A major focus of the DCRI isto design, procure and implement a new ClinicalResearch Information System (CRIS). During thepast year much progress has been made toward thisacquisition. Extensive customer input has beenreceived and a general plan for acquisition of theCRIS backbone (replacing the old MedicalInformation System) has been developed. In addi-tion, during the past five years the CC Budget officehas implemented an activity-based costing systemthat provides markedly improved resource utiliza-tion data to IC customers. The CC has alsoembarked on a major project to track patient careactivity in clinical protocols (i.e., ‘protocol map-ping’). These projects provide the infrastructure forfurther progress in financial accountability andresponsiveness to our customers’ and stakeholders’needs for more accurate financial and planninginformation. The CC has recently completed andlaunched a third project, the creation of a Web-based CC “Service Formulary” that details all of theservices provided by the CC and the ICs.

• CC successes are not adequately communicat-

ed to the public, to referring physicians, and to

the insurance and managed care industries.

The Options Team report concluded that, “Theoutstanding work of the Clinical Center is not beingcommunicated to those outside NIH in an effectivemanner. The public, insurers, and referring physi-cians must be informed about the ways that theClinical Center promotes the highest standards forconducting research and training researchers.”19

To address problems previously identified by focusgroups and by external consultants, the CC hasdeveloped a marketing plan, which includes lettinga substantial contract to develop a public rela-tions/marketing initiative and the creation of theOffice of Patient Recruitment and Public Liaison.The CC Board of Governors endorsed the patientrecruitment project as part of the long-range goalsincluded in the strategic plan. The three major com-munications goals of this new Office are:

• To increase the visibility of the CC as a nation-al center for clinical research

• To increase recognition of the CC as a nationalcenter for the training of clinical investigators;and

• To educate the public about clinical research.

• Through the end of the 1990s patient recruit-

ment efforts were viewed as increasingly less

successful.

For a variety of reasons, patient recruitmentdecreased, despite significant efforts by theresearchers to recruit patients, some excellent and,in some instances, important studies have lan-guished for lack of patients.

As noted above, the Office of Patient Recruitmentand Public Liaison has, as it’s primary mission, thesupport of patient recruitment and referral efforts.The primary goal of the service is to increase theenrollment, including women and minorities, toclinical research studies in the CC. Performancedata from this new service suggest a brisk responseto these efforts. Concomitant with these efforts andthose of the ICs to rebuild and bolster their intra-mural clinical research programs, for the first timein several years, CC inpatient activity increased.


• Although not offering “full services” was per-

ceived as an organizational strength because it

permits organizational efficiency and flexibility,

not offering complete, integrated medical and

surgical services can also be viewed as an

institutional weakness.

The fact that the CC does not provide full servicesis perceived by some CC and IC staff as a disadvan-tage for several reasons. For some physician researchtrainees, the fact that the CC does not offer “full-services” limits the desirability of the CC as a train-ing site. Not offering these services necessitatesdeveloping procedures to acquire some types of sup-port from local academic or community physicians.Response times for outside consultants are occa-sionally less than optimal. Additionally, their invest-ment in, and commitment to, the CC patient pop-ulation is almost invariably less than that of theNIH investigators. Because the CC does not see afull spectrum of illness, maintaining clinical compe-tencies and training staff is difficult and oftenrequires relationships with extramural institutions.To address these issues the ICs and the CC haveforged alliances with extramural institutions. Someexamples of these alliances include:

• Partnerships with Johns Hopkins Universityand the National Rehabilitation Hospital thatwill facilitate clinical training for fellows andjunior staff and will afford senior staff theopportunity to maintain clinical skills;

• A partnership with Johns Hopkins andSuburban Hospital that will facilitate the con-duct of studies of acute medical problems (e.g.,brain attack, myocardial ischemia) that hereto-fore have been impossible at the CC, primarilybecause of the absence of an Emergency Room;this program opened officially in May 1999;

• A partnership with Duke University and theUniversity of Pittsburgh to facilitate advancedtraining in clinical research, including theopportunity to receive an advanced degree inClinical Research; and

• A variety of partnerships with local institutions(e.g., Washington Hospital Center, JohnsHopkins, Georgetown, and others) to provideCC an opportunity to maintain clinical compe-tencies.

These extramural affiliations should strengthentraining opportunities. Currently, IC staff providesthe overwhelming majority of consulting services;traditionally, these consulting services have beenmanaged by ICs maintaining clinical research inter-ests in those fields. No formal system of accounta-bility or responsibility exists for the consultationservices. For this reason, not all ICs have empha-sized the importance of responsiveness in clinicalconsultation, nor do their clinical services put forththe effort to maintain their clinical expertise. Inmid-1997 the Medical Executive Committee formeda subcommittee to address the perceived problemswith consultative services. The first steps in address-ing the issue were: 1) to obtain IC agreement aboutthe “ownership,” or responsibility for, the variousconsultative services present in the CC; 2) to developa system, based in the CC’s Medical InformationSystem, to collect information from both consultantsand those requesting consultations about the timeli-ness, appropriateness and the quality of consultationsprovided by consultative services. The overall goal ofthe Medical Executive Committee’s subcommittee isto increase the quality of care provided to clinicalresearch subjects at the CC.

The CC has also made a substantial commitment toincrease the quality and availability of clinicalresearch training over the past four years, asdescribed above. The NIH Director also establisheda “Clinical Research Training Program” for medicalstudents (analogous to the Howard Hughes MedicalInstitute-funded training program in the basic sci-ences). This program was established 36 months agoand is now completing a very successful third year.Students have the opportunity to take courses, whileunder the mentorship and working on clinical proj-ects with, successful intramural clinical researchers.

In response to concerns raised by patients and theclinical staff of the CC about the efficacy of symp-tom management strategies in the institution, theCC assembled a panel of experts in PainManagement and Palliative Care for a conference atthe Stone House on the NIH main campus. Thispanel provided the organization with additionalimpetus to create a Pain Management and PalliativeCare Service for CC patients. The CC convened asearch committee and recruited a Chief of this newservice, Dr. Ann Berger. Patients and staff, alike, havereceived this service enthusiastically. The team hasbeen in place for more than a year. The service usesboth traditional and nontraditional approaches tohelp alleviate pain, other symptoms and suffering in


our patients and has become an integral part ofquality care in the CC.

The CC has also recruited an exceptional GeneralInternist and two Nurse Practitioners to provideInternal Medicine consultations for CC patients.This service was initiated in 1998 and has met withenthusiastic approval. Based on ongoing perform-ance measurement data, the service has becomebusy enough to warrant the recruitment of a secondinternist. The CC hopes to have this individual inplace by January 2002. In addition, the CC recruit-ed a second pediatrician to provide general pedi-atrics consultative support.

• Communication practices are inconsistent

across the CC and the NIH.

At its department heads retreat in 2001, CC staffidentified inadequate interpersonal communicationbetween CC and IC staff as a major organizationalobstacle. Retreat attendees underscored that inade-quate communication within the organization (i.e.,among departments, between administration and thedepartments, and between the administration andline staff), as well as communications with majorstakeholders (i.e., CC – IC interactions, physician –patient interactions, and physician referring interac-tions) were in need of significant improvement.

• The CC has not routinely sought customer

input about its services.

As a service organization, customer input is crucialto smooth functioning of the CC. In 1997, the CCinitially partnered with the Harvard-based PickerInstitute for its initial patient survey. Results fromthe survey identified areas that needed attention inthe organization, but also established new qualitybenchmarks for the Picker group in terms of overallperceptions of quality. Picker was sold to theNational Research Corporation (NRC) in 2001;however, the Picker ‘perception’ surveys will remaina part of the NRC portfolio, so the CC will be ableto maintain continuity in its customer perceptionprogram. This coming year an outpatient survey, apediatrics survey, and an employee survey areplanned. In addition, plans are being formulated fora survey of referring physicians. The CC Directorestablished a Patient Advisory Group in 1998. Thisgroup is composed of current and former patientsand provides the Director with the patient’s per-spective about service quality in at the CC. Thisgroup has also helped identify issues that have

become the focus of performance improvementactivities (see customer service initiative, below). Toimprove interface with the public, to improve out-reach to minority and underserved communities,and to assist in recruitment for clinical trials, the CCalso established the Patient Recruitment and PublicLiaison Center. This new center has had a substan-tial salutary effect on both patient recruitment andcommunity relations since its inception three yearsago.

• Customer service has not been an identified

institutional priority.

The CC Director’s Patient Advisory Group identi-fied a need for organizational improvement in thearea of basic courtesy and customer service. Inresponse to this identified need, the CC hasembarked on a major customer service initiative. Anexternal contractor has been hired to train staffthroughout the organization – focusing particularlythose at major customer/stakeholder interfaces.Anecdotal reports from members of the PatientAdvisory Group suggest that the training is alreadybearing fruit. This training will also be offered toother NIH and contract staff (i.e., outside of theCC) that interacts with CC patients and the public.

• The CC has substantial opportunities to

increase its attention to workforce diversity

and healthcare disparities.

During the past five years both NIH and the CChave also become increasingly aware of an organiza-tional need to honor cultural diversity and to developpolicies of inclusiveness for the CC workforce andeveryday practices. The NIH Acting Director hasidentified health disparities as a major NIH priority.The CC has successfully competed for funds fromthe NIH Center for Minority Health to facilitaterecruitment of minorities into clinical studies. Inaddition, the CC has embarked on a major diversityawareness program and has redoubled its efforts torecruit minority staff. As part of this effort the CC hasestablished a summer student-training program thatfocuses on the recruitment of minority students.


Assessing the external and internal environ-ments will afford the CC the opportunity to addressseveral important questions, the answers to whichwill help shape the CC’s vision for the future.Among these important questions are the following:

• What external forces or trends are influencingthe CC environment?

• How are these forces or trends currently influ-encing the CC and how will they likely influ-ence the manner in which the CC operates inthe future?

• How is the CC positioned to manage thesetrends?

These external and internal influences and trendswill undoubtedly present the CC with both oppor-tunities and challenges. Thus, the analysis of thesefactors will include both “CC opportunities” and“CC challenges for the future.” A number of theseexternal factors simultaneously present opportuni-ties and threats.

CC staff visited many centers across the countrythat are viewed as “best-in-class.” In discussionswith the leaders of these organizations, many factorsdriving change in the healthcare and clinicalresearch environments were identified. These factorscan be divided into “challenges and opportunities”and can be loosely grouped into several general cat-egories:

• Changes in, or influenced by, societal values;

• Changes influenced by cost considerations;

• Process changes in healthcare driven by increas-ing competition, such as the rise of managedcare;

• Changes influenced by shifts in population and

population demographics;• Changes in the practice and delivery of medicine;

• Changes in practice driven by technologicaladvances;

• Changes influenced by governmental initia-tives; and

• Changes mandated by agency priorities and ini-tiatives.

As a result of the dramatic changes taking place inscience, medicine, and the healthcare industry, theCC faces the following opportunities, challenges,and potential threats.

Societal & Value-Based Factors

The political climate, the potential for increased acts ofterrorism, and the declining economy will add a degreeof instability to the NIH environment over the nextfew years.

Terrorist acts directed against the U.S. haveincreased steadily over the past years. The potentialfor additional acts of terror, including bioterrorism,seems likely, if not inevitable. The declining econo-my and the need to focus resources on nationaldefense and public safety may mandate changes inour internal environment. The CC is working toanticipate some of these problems, by revising andbroadening its disaster plan, by preparing for the‘soft landing;’ and by working to increase organiza-tional efficiency.

U.S. society has steadily increased its perceptions ofsocial responsibility.

Society has become more attuned to social responsi-bility for healthcare delivery since the 1960s.Interest in, and expenditures for, medical care forthe elderly and the socially disadvantaged hasincreased dramatically during the past 30 years. The

Factors in the External and Internal Environments Influencing Change in Healthcare Delivery and Clinical Research 17

Factors in the External and Internal EnvironmentsInfluencing Change in Healthcare Delivery and Clinical Research

costs associated with providing care to elderly andindigent patients have begun to stress the healthcaredelivery system. The increased social awareness hasled to an increased appreciation of the role of alco-hol and substance abuse in society, has shed light onthe unique health problems associated with aging,and has clearly contributed to the founding of theNational Institute on Aging, the National Instituteon Alcohol and Alcohol Abuse, and the NationalInstitute on Drug Abuse. This trend toward increas-ing social responsibility provides NIH and the CCwith an opportunity to create and conduct land-mark studies in these important areas. Conversely,because of increasing social responsibility, some inU.S. society would prefer to divert research dollarsto support current costs of medical care. Such anapproach is particularly understandable in the short-term, but may be more costly in the long run.

Americans increasingly value the “Quality of Life.”

In the past 25 years, society’s focus has subtly shift-ed from “staying alive” to the “quality of life.”Americans have become much more conscious of“quality of life” as an endpoint or outcome andAmerican medicine has, by necessity, been forced toaccommodate these value changes. As Americansociety has turned attention to this issue, Congresshas also developed an interest in “quality of life” con-cepts. This shift in societal focus provides the intra-mural program and the CC with the opportunity toinclude objective and subjective measures of thefunctional outcomes that contribute directly to the“quality of life” as outcomes of clinical research proj-ects. Particularly in oncology studies, patients’ valuesand individual, unique measures of “quality of life”may influence therapy choices. CC departmentssuch as Rehabilitation Medicine, Pharmacy,Anesthesia and Surgical Services, and Critical CareMedicine have unique opportunities to contribute toCC studies in this area. Although not traditional‘clinical care,’ this unique ‘clinical research support’ isan important component of the support provided byvarious CC departments. Ignoring this importanttrend in its clinical studies could place the CC at adisadvantage in the eyes of its societal customers.Since the first edition of this document, public inter-est in “quality of life” issues has not waned. If any-thing, interest has intensified. Healthcare institu-tions have developed strategies to begin to measurechanges in the “quality of life” that are effected byvarious therapeutic alternatives. These measurementstrategies are a direct outgrowth of the persistentpublic interest in “quality of life” issues.

Wellness and prevention strategies are increasingly valued.

In the past three decades, U.S. society has increas-ingly focused attention on nutrition, diet, exercise,and avoidance/cessation of smoking and alcoholconsumption. This focus on health and wellnessalso provides the NIH intramural program withclear opportunities to study basic mechanisms ofhealth and the pathogenesis of disease states relatingto this societal focus.

In response to society’s interest, NIH has increasedits investment in wellness and prevention activities.In a speech at Stanford University Medical Schoolin 1997, the NIH Director underscored the NIHcommitment to these activities and enumerated theways in which NIH has become increasingly invest-ed in wellness and prevention strategies. The exter-nal focus on “prevention” and “wellness” has con-tinued to intensify over the past 30 months.Prevention activities are, in general, among the mostcost-effective interventional strategies. For these rea-sons, this trend is likely to continue for the foresee-able future.

Technology in medicine is advancing almost exponen-tially; technologic advances are highly publicized; thus,these advances become “desired.”

Medical technology blossomed in the 1990s. Toolsof medicine have changed more during the last 40years than in all five hundred years past. NIH con-tributes to this rapidly advancing field, and as aresult often has unique opportunities to use thesetechnologies as they are being introduced into soci-ety to investigate the frontiers of medicine. Since theCC is ideally positioned to adapt swiftly to thedevelopment of new technologies, such rapidlyadvancing technologies provide the CC with aunique opportunity to enhance its national andinternational reputation as a creative, innovativeinstitution. Such new technologies often have directimpact on cost. Occasionally the required capitalexpenditures for new equipment are quite large andsome technologically advanced procedures are laborintensive. These changes tend to increase the costsof care. In other instances introduction of newtechnologies have been associated with less invasiveprocedures and decreased length of hospital stays(e.g., laparoscopic cholecystectomy), therebydecreasing the net costs of care, despite the outlayfor the necessary capital equipment.


The delineation of the human genome has resultedin a proliferation of studies in the field of genomicsand proteomics that are likely to quickly move sci-ence to more sophisticated, gene-based studies and,to a younger patient population. The focus ongenomics may also, ultimately favor preventionstudies.

A general trend in the CC over the past several yearsis toward increased intensity/acuity of services perpatient visit (i.e., more sophisticated imaging stud-ies, more molecular tests per patient visit, increasingnumbers of serial studies, etc.). Many such studiesare outside the bounds of what would traditionallybe characterized as standard care but easily fit underthe rubric of clinical research support.

During the past five years, the CC has continued toinvest in new technologies, trying to position itselfat the forefront of academic institutions in thisarena. Several new initiatives in this area are alreadyin progress. These include a public-private collabo-ration to create a new, state-of-the-art cell processingfacility, and the purchase of new infared imagingtechnology, new stereotactic neurosurgical equip-ment and an upgrade in magnetic resonance imag-ing capacity. There is also more emphasis on molec-ular diagnostics in Laboratory Medicine andTransfusion Medicine and the creation of a newimaging center, in collaboration with NHLBI,NINDS, and Suburban Hospital (Bethesda, MD),specifically designed to study acute cardiac and neu-rological vascular events in the Suburban Hospitalemergency room.

Some sectors of the U.S. population have become high-ly suspicious of “clinical research.”

As a result of adverse publicity arising from certaininfamous clinical studies (e.g., the Tuskegee study,the Willowbrook studies), some segments of theU.S. population have developed a substantial mis-trust of the entire clinical research enterprise.Developing programs that reach out to these seg-ments of society with sensitivity could enhance theCC’s reputation and result in a renewed patient-recruitment base. Congress and DHHS could viewineffective recruitment of women, minorities, andunderserved populations with disdain. Recentadverse publicity associated with serious adverseevents resulting from clinical research, the cloning offarm animals, and the proposal to clone humans maypresent additional problems with certain aspects ofthe public’s perception of biomedical research.

CC leadership has attempted to reach out to severalminority communities who have not been tradi-tionally invested in the clinical research process. Forexample, the CC’s Office of Patient Recruitmentand Public Liaison has interacted with the localHispanic community, and the Director of theClinical Center made a presentation to the AnnualMeeting of the National Medical Association. TheOffice of Patient Recruitment and Public Liaisonhas also produced a video to assist in the recruit-ment of minorities to clinical research studies. Inaddition, the CC has created a website describing allactive clinical research protocols at the CC. The CChas also established a new Clinical Bioethics depart-ment, which enables the organization to address thecomplex issues associated with cultural biasestoward participation in clinical research.

Population & Clinical Research Subject-BasedExternal Factors

Patients and clinical research subjects are becomingincreasingly sophisticated healthcare consumers.

Consumerism is a relatively new phenomenon inU.S. healthcare. Because of the free availability ofdata, individuals have access to much more infor-mation about medicine and healthcare. As a resultof the increasing publicity associated with iatrogenicand nosocomial medical misadventures, and as aresult of the increasing media coverage of progressand problems in healthcare, the special standing ofphysicians in the community – the mystique of thewhite coat – has essentially disappeared. As health-care costs have escalated, to try to maintain profitmargins, insurance companies have increased co-payment rates, and patients are now paying anincreasing fraction of healthcare costs out of theirpockets. For this reason the healthcare customer hasbecome much more interested in cost and qualitycomparisons when procuring healthcare services.Since the CC delivers high quality healthcare with-out charge to participants in its clinical studies, andas healthcare customers focus more intensely on costand quality, the CC should have an opportunity tomore effectively recruit study subjects by appealingto both patients and providers. In addition, as thefocus on cost and quality increases, the CC shouldhave the opportunity to become better recognized asan outstanding clinical research facility.

In the 60 months since the strategic plan was ini-tially drafted, consumerism in healthcare in theUnited States has continued to increase. Numerous


healthcare organizations have organized themselvesalong medical product lines, and public advertisingof these product lines (e.g., imaging services, man-agement of coronary artery disease) has increased.Consumers of healthcare in the United States in1999 are focusing on several issues, among them: 1)ready access to healthcare and to their healthcareproviders; 2) provider responsiveness to questionsand problems; and 3) the level of customer serviceavailable from their providers.

Scientific literacy is decreasing in the U.S.; science edu-cation in the U.S. is not keeping pace with Europe andAsia.

At the same time that consumerism in healthcare isburgeoning, the quality and efficacy of science edu-cation in the U.S. is not keeping pace. Studies con-ducted by the Congressional Office of TechnologyAssessment, the National Science Foundation, andthe American Association for the Advancement ofScience have suggested that science education in theU.S. is lagging substantially behind that of Europeand the Far East. Comparing the results from 15developed nations of international standardizedtests, U.S. students placed last in biology, third fromthe last in chemistry, and fifth from last in physics.Further, the talent pool entering science occupa-tions is also diminishing. For example, the percent-age of National Merit Scholarship finalists enteringcareers in science, the health sciences, and engineer-ing have been steadily decreasing. If the net impactof faltering science education in the U.S. is that sci-ence per se is valued less in U.S. society, the likeli-hood that biomedical science discoveries and sci-ence-based health interventions – the forte of theNational Institutes of Health – will be undervaluedor misunderstood is increasing.

Societal demographics are changing.

Life expectancy is lengthening; therefore the U.S.population is becoming older. Older patientsrequire more healthcare and develop different med-ical problems. When coupled with the value shiftsnoted above, these demographic changes subtlymodify the national research agenda. This modifiedagenda provides NIH scientists with scientificopportunities. In addition, the demographics oflarge metropolitan population centers are alsochanging. The percentage of minorities and under-served individuals in the populations of major U.S.cities continues to increase. As these populationscontinue to expand, the CC is faced with the chal-

lenge of developing effective communication strate-gies with these segments of society. Since healthcaredelivery to these populations is currently subopti-mal, the development of effective communicationstrategies might serve both the interests of thesecommunities and the CC by offering access to aquality of healthcare otherwise not available, whilesimultaneously providing a source for patientrecruitment.

Society has become increasingly litigious; malpracticeclaims have increased dramatically; malpractice insur-ance rates have escalated almost exponentially.

The costs associated with the unprecedented rise inthe number and size of malpractice suits over thepast three decades have contributed significantly tothe escalation of healthcare costs in the U.S.Although the CC has had few such claims, thenumber of claims is increasing, and the CC is, by nomeans, immune to these actions. This trend pres-ents a challenge to develop effective mechanisms forassuring quality; both in the studies conducted atthe CC, as well as in the care provided to CC clini-cal research subjects. In addition, the challenge pre-sented by an increasingly litigious society shouldgalvanize the CC to seek “customer” input regard-ing the quality of services provided.

“Alternative and complementary” medicine is assum-ing an increasingly visible role in U.S. medicine.

The public has long been interested in alternativeand complementary medicine. Whereas medicineand society unquestionably have a great deal to learnfrom “nontraditional” and “cultural” remedies andtreatments, the term “alternative and complementa-ry medicine” has often been used to shroud medicalfraud. “Miracle cures” such as Krebiozen andLaetrile often turn out to be far less effective thanthey are originally touted. The increased societalinterest in alternative and complementary medicineproffers the challenge to the intramural programthat NIH develop open lines of communicationwith its clinical research subjects and the public onthese issues. Failing to give credence to the possibil-ity that non-traditional remedies and treatmentsmay have real value runs counter to the science-based culture of NIH. NIH as a truly unbiased,impartial community is ideally situated to addressissues such as the safety and efficacy of nontradi-tional approaches to medical care.


In the late 1990s, NIH has increased its emphasis onthe evaluation of alternative and complementarymedicine. A Center for Alternative andComplementary Medicine has been created at NIH.Funding for studies of these approaches has beenincreased. Major clinical trials of alternative and com-plementary therapies funded by NIH are in progress.The emphasis on alternative and complementarymedicine is also apparent in the CC where for thepast several years an external consultant skilled inacupuncture has been providing treatment patientswith chronic pain. In addition, a senior StaffClinician from the CC department of RehabilitationMedicine has been trained to perform acupuncture.More recently, the CC has established a Pain andPalliative Care Service (described previously in moredetail).

Cost-Based External Factors

Cost continues as a major driving force in the U.S.healthcare industry.

In the past two decades healthcare costs have esca-lated exponentially, primarily at consumers’expense. The Federal government, as well as stateand local governments has become intensely inter-ested in controlling costs. These interests have led toformal scrutiny of the systems and processes in med-icine and in healthcare delivery. Cost considerationshave had a profound impact on the healthcareindustry in the U.S., leading to: 1) increasedreliance on the use of business management theory(e.g., CQI, reengineering, etc.) to attempt to gener-ate efficiencies in the healthcare industry; 2) a care-ful assessment of the substantial variation in pat-terns of care of individual diseases or conditions; 3)a call for standardization of practice across the coun-try; 4) an increasing trend toward the systematiza-tion of medicine – evaluation of outcomes, stan-dards of care, clinical guidelines/pathways/caremaps; 5) a remarkable shift toward capitation, man-aged care, and vertically-integrated healthcare sys-tems; 6) a dramatic shift away from subspecialtymedicine and an increased emphasis on primarycare; 7) more reliance on non-physician primary-care and extended-care providers; 8) an aggressivetrend toward early discharge and emphasis on out-patient medicine; 9) aggressive competition forhealthcare customers; and 10) major centers aggres-sively streamlining, downsizing, cross-training, andseeking new, more efficient models of care.

Cost considerations have led to a rethinking of suchpivotal issues as the basic processes and models ofcare delivery; the increasing reliance on non-physi-cian primary care providers; an increasing penetra-tion of managed care into the healthcare market-place; a dramatic increase in competition forpatients; and a shift to outpatient and primary caremedicine, among many others. Whereas the costs ofcare and payment for care are primary drivers for thehealthcare industry, the regulatory environment andthe human subjects protection rules are the primarydrivers in the NIH/CC environment. The CC findscommon ground with the healthcare industry in theneed to maintain fiscal accountability to customersand stakeholders. Several of the newer strategies andapproaches have also become highly visible in theCC in the past five years, including increased use ofphysician extenders and a continued shift towardoutpatient and day hospital studies.

Spiraling costs associated with healthcare and clini-cal research also led to a downturn in clinicalresearch investigators on the NIH campus. Forexample, in 1997, the campus had only 386 inves-tigators who were principal investigators on clinicalresearch studies. During the past three years, thecampus has witnessed a resurgence of interest inclinical research, fueled both by the NIH Directorwho has challenged the ICs to produce cutting-edgetranslational research as well as by the constructionof a new Clinical Research Center. By the end of2001, 417 principal investigators had active clinicalresearch protocols, the highest number since 1995.

These dramatic trends provide numerous opportu-nities and threats to the CC and to the NIH intra-mural program.

• Adoption of new business management princi-ples will likely foster organizational efficiencies.Organizational efficiencies remain an institu-tion-wide focus for the CC. Despite thisemphasis on efficiency, the CC has, nonethe-less, been able to support substantial growth insome areas (e.g., the development of the stem-cell/cell processing facility, creation of a newClinical Bioethics Department, substantialinvestment in state-of-the-art imaging technol-ogy, and increased investment in informationsystems support, among others).


• Evaluation of protocol-based care in a manneranalogous to “critical pathways” will likely facil-itate the development of a meaningful protocolbased cost-accounting system, while simultane-ously expediting staffing assignments and orga-nizational planning. Such an approach will alsoprovide a template for evaluating the clinicalquality of the care delivered in the protocol aswell as the extent to which patients are able toadhere to the protocol as it is written.

• The CC has developed an initiative to map allof the active clinical research protocols. Thesemaps provide a template for the research planand the requisite services but also serve to delin-eate the resources needed to support these stud-ies. During the past two years, new software tosupport the protocol mapping process has beenpurchased and a contractor has been hired tofacilitate the implementation of the software.The Director of the Clinical Center hired aSpecial Assistant who has extensive administra-tive experience at the University of Maryland tospearhead the protocol-mapping project.

• The shift to a capitated clinical environment inthe external community provides both oppor-tunities and threats. Managed care organiza-tions may well be interested in referringpatients who would require large financialexpenditures for care; conversely, some man-aged care organizations believe they may belegally barred from referring patients.

• In response to continued interest from theOffice of Management and Budget in havingthe CC bill third-party payers for some aspectsof the care provided at the CC, leadershipdeveloped a four-pronged approach, including:developing a legislative process under which theCC could be granted the authority to bill third-party payers for care delivered to enrollees par-ticipating in clinical research; establishing a dia-logue with managed care representatives con-cerning their interest in, and willingness to,support clinical research at the CC; developingan infrastructure to track the costs of partici-pating in clinical research; and prospectivelycollecting insurance information from CCpatients to determine the fraction who haveinsurance coverage and the potential impact ofasking clinical research subjects’ insurers tocover some of the costs of their care at the CC.

• In 1996 Congress provided language in theNIH Authorization that permitted the CC tocollect from third-party payers. In February andMarch, 1997, the CC held meetings with rep-resentatives from insurance companies, man-aged care organizations large, self-insured cor-porations and from the Health Care FinancingAdministration (HCFA) to discuss the poten-tial for recovery of some of the costs of clinicalresearch and to address the possibility of broad-ening the CC’s referral base to encompasspatients from health maintenance organizationsand large insurer networks. The meeting pro-vided CC leadership a great deal of insight intothe current status of the insurance/managedcare industry. The CC also conducted a six-month study of the insurance status of patientsparticipating in clinical research studies at theCC. The CC’s Board of Governors reviewed allof the information collected in this process,and, after careful consideration of the informa-tion recommended against the CC pursuingthird-party payment for clinical research per-formed at the CC.

• The shift toward primary care has resulted infewer high-quality young physicians in the fel-lowship pools, and less interest in clinical andbasic science among medical school graduates.Many fellowship-training programs are closing.These trends clearly will have an impact on themanner in which the CC provides care to itsclinical research subjects, as well as on the ICs’clinical and basic science training programs.The CC and the other intramural clinical train-ing programs will have to compete with themajor academic institutions for this smallerpool of highly qualified applicants.

• The trend toward the use of non-physicianproviders affords the CC an opportunity toevaluate the model of patient care currently inuse and to consider the creative use of non-physician primary care providers in intramuralclinical research. In addition, the creative use ofsuch personnel may help solve the problemgenerated by the ever-diminishing fellowshippools.

• The trend toward outpatient medicine, whichis paralleled in the CC’s operating statistics,provides an opportunity for CC scientists todevelop creative, less expensive and labor-inten-sive protocols that can be conducted in the out-


patient clinics. This trend should be useful toCC and IC management in terms of reducingthe costs of clinical research.

• Competition among healthcare delivery organ-izations for patients has become even more of adriving force in the healthcare environment inthe past 60 months. The aggressive competitionfor patients and clinical research subjects pro-vides both opportunities and challenges to theCC. The intense competition for patients willlikely make recruiting patients for clinical stud-ies more difficult. Competition has already hada profound impact on the academic medicalcommunity. Institutions that used to operateprofitably and that used to have substantialexcess revenues that could be used to help fundclinical research projects have had to scrambleto remain solvent. High quality institutionscontinue to seek partnerships with the CC tofacilitate their research and training agendas, toincrease their visibility in certain markets, andas a marker of the prestige of the institution.The CC’s new extramural alliances (discussedabove) should strengthen its and its partners’competitive positions.

• The explosion in technology provides the CCwith a unique opportunity to use these cutting-edge technologies to develop less expensive typesof care. The CC is uniquely situated to addressthe challenge of developing medical technolo-gies that reduce the costs of medical care.

In the time that has elapsed since the initialdrafting and subsequent revisions of this docu-ment, most of the issues described above relat-ed to healthcare costs have persisted. Two mayhave receded a bit; though, at the time of thiswriting, the extent to which they have recededis not clear. The first of these is the nearly expo-nential increase in capitated, managed care. Insome areas the healthcare market may havebecome saturated with health maintenanceorganizations and managed care providers. Inother areas of the country interest in fee-for-service medicine has been rekindled. Second,the trend toward early discharge has receivedboth public and Congressional scrutiny andmay have been reversed, at least for some spe-cific circumstances. The subtle changes thathave occurred will likely exert minimal influ-ence on the extent to which cost considerationsinfluence the CC environment. Despite these

somewhat subtle changes, cost considerationscontinue to be the primary influence on changein healthcare in the U.S.

Medical Practice-Based External Factors

Medicine, the practice of medicine, and the conduct ofclinical research are changing rapidly; progress in bio-medical research produces natural change in theresearch agenda.

Medical progress keeps sicker patients alive formuch longer periods of time. As a result, suchpatients often remain at risk for care-requiring com-plications for extended periods of time. Such com-plications are often expensive and labor intensive.Rapid progress does, however, present unique chal-lenges to the management and leadership of theCC. Rapid progress precipitates abrupt shifts in theresearch agenda, and often necessitates fast procure-ment of expensive new equipment, reagents andpharmaceuticals. The CC is ideally situated toreprogram resources to address new scientificopportunities for translational research. For exam-ple, since the last edition of this document, the CChas worked with several ICs (e.g., NIDDK, NIMH,NIAMS) to design and implement innovative newclinical research programs.

Effective planning is essential to keep an organiza-tion the size of the CC aligned with the NIH mis-sion, the CC’s mission and vision, and the ICs’ rap-idly changing research agendas. Management mustremain attuned to the intramural and extramuralresearch cultures, must be able to predict, or at leastdetect, where progress will occur, and position theorganization to capitalize on the progress. Whennew technologies are identified, the CC must assessthe intramural need, and, where appropriate, adoptthe new technologies, and make them available tothe intramural scientific community. The manage-ment of the CC has to maintain effective commu-nication with IC leadership to stay aware of progressas it occurs. Further, the CC departmental leadersmust be flexible enough to reprogram resources andembrace progress as it occurs. Only in this way willthe CC be able to supply the quality of clinicalresearch infrastructure necessary to accomplish itsmission. In the time period following the drafting ofthe original environmental assessment, the empha-sis on molecular medicine and molecular techniqueshas continued to increase.


The characterization of the human genome hasspawned the fields of genomics and proteomics.These two fields will likely help shape a substantialfraction of the future of clinical research studies onthe NIH campus for the foreseeable future.Information systems technology is advancing almostexponentially and the explosion of this technology isfueling advances in many other biomedical researchdisciplines. The marked shift toward molecular medi-cine has engendered numerous additional changes inthe complex CC environment. Molecular techniqueshave made it possible to identify patients who, eitherinvariably or with a much higher frequency that thegeneral population, will develop debilitating diseases.Remarkable opportunities for evaluating host respons-es to illness have recently become available throughthe use of computerized assessment of gene expressionby microchip gene arrays. Scientists are just beginningto unmask the potential of this new technology. Thedevelopment of molecular techniques has also raisedcomplex questions requiring increased reliance onbioethicists in making decisions regarding geneticcounseling, gene therapy, genetic experiments, and themanagement of results from genetic tests. Secondly,the move toward molecular medicine has fosteredincreased investment in the technology needed toconduct these experiments and in personnel expert inmanaging the extraordinary data sets engendered bythis technology. Third, this trend has produced achange in the manner in which we interact with ourpatients. In the past, extended hospitalizations mayhave been needed to conduct a study. For some ofthese experiments, a single phlebotomy may be ade-quate. Consequently, the CC has observed a substan-tially decreased length of stay and less reliance onpatient admissions to conduct these studies. Finally,the complexity and specialization inherent in molecu-lar medicine has mandated increasing collaborationamong scientific disciplines and has resulted in a cleartrend toward more cross-IC projects.

All healthcare institutions are being asked to measureperformance and to demonstrate performanceimprovement.

Medicine has begun to focus on costly variation inpractice as well as on the benefits of standardizationof the processes of care. The past three years haveseen an increased focus on the industrial model of‘performance measurement’ and outcomes assess-ment in healthcare. The focus on performancemeasurement has emphasized the importance fororganizations and for components of organizationsto have clearly measurable outcomes and processes.

In addition, regulatory agencies, such as the JointCommission on the Accreditation of HealthcareOrganizations (JCAHO) require that healthcareinstitutions demonstrate performance improvementactivities.

Patient safety and human subjects protection in clini-cal research have become increasingly important.

As a result of the Institute of Medicine’s report, “ToErr Is Human,” the nation – both the lay public andthe healthcare industry – has been made even moreacutely aware of the importance of patient safety.Similarly, misadventures and mistakes in clinicalresearch have given rise to increased scrutiny of theresearch environment and have resulted in increasedregulatory requirements for a prescribed infrastruc-ture to be in place to facilitate the conduct ofresearch. NIH has been at the vanguard of this issue;the Medical Executive Committee published a set ofStandards for Clinical Research and a process hasbeen put in place to assure each IC’s compliancewith the standards. In addition, the NIH has vol-unteered to have its clinical research program evalu-ated as a pilot for an organization that plans todevelop an accreditation process for clinical researchsomewhat analogous to JCAHO accreditation forclinical care.

Another way in which the institution has respondedto concerns about human subjects’ protection is todevelop programs to train investigators in the prin-ciples and practice of clinical research. The CC wasamong the first organizations in the nation torequire completion of a basic course in clinicalresearch principles in order to be an approved inves-tigator on a protocol. In addition several other clin-ical research-training courses (described previouslyin more detail) address this identified need.

The healthcare industry is also experiencing a nation-al shortage of nurses, pharmacists, and medical andradiological technical staff.

The past three years have seen a worsening of a pre-existing problem – a national shortage of crucialpatient care and clinical research support personnel.Substantial workforce shortages have developed innursing, pharmacy, clinical and imaging technicalstaff, and information technology personnel. In2001, the CC is actually faring extremely well inthese areas (i.e., with less turnover and fewerunfilled positions compared with other institutionsin our community).


Nonetheless, all these shortages present potentialthreats to CC operations, should they become moresevere, and should the CC be unable to use itsunique and attractive work environment to over-come market pressures. Therefore, the CC is assum-ing a proactive stance, including alternative person-nel authorities to speed the hiring process, makinguse of all available mechanism to create and main-tain a competitive salary and reward structure, andaggressively marketing CC job opportunities.

Information systems technology is changing the face ofmedicine.

The role and importance of information systemsmanagement in medicine is changing dramatically.The CC is well situated to take advantage of theremarkable opportunities presented by the ongoingrevolution in information systems management.Teleconferencing and telemedicine are likely to beof great value in the recruitment and managementof patients at sites far removed from the CC. Inaddition, the striking progress in information sys-tems technology presents unique opportunities to:1) improve the quality of care provided to CCresearch subjects; 2) improve the training of clini-cians; 3) create substantial efficiencies in the mannerin which clinical research subjects are managed inthe institution (e.g., display of histological sections,radiographs, magnetic resonance and computedtomography scans, electronically at the patient’sbeside or in the investigator’s office, as soon as thestudies have been interpreted); and 4) use the sub-stantial expertise in clinical information systemsmanagement that has been developed over the past20 years to produce an integrated system that meetsclinical, fiscal, and managerial needs. The CC clear-ly needs to integrate its patient care information sys-tem with a real-time, effective managerial and fiscalsystem. In addition, the CC is faced with the chal-lenge of integrating three different types of dataessential for managerial efficiency: 1) clinicalpatient-care data; 2) cost-accounting data; and 3)research-laboratory data. The challenges associatedwith the rapidly accelerating field of medical infor-mation systems management are: 1) staying abreastof the technology as it advances; 2) assuring thatcomponents of the organization have adequateinformation systems support to conduct its businessefficiently and effectively, while simultaneouslyassuring that these systems are compatible with eachother; and 3) making certain that the organization isconsistently investing an appropriate amount of itsresources into information systems technology. The

information systems expertise already present on theNIH campus, combined with the investigationalmandate of NIH, provides an ideal milieu for thedevelopment of automated, clinically relevanthealthcare systems.

In the past three years, the CC has increased itsinvestment in information systems technology dra-matically. During this time, the CC has effectivelydoubled the labor force working in the informationsystems area. The number of ongoing CC projectsinvolving information systems improvements issubstantial (detailed above). In addition, plans forthe new Clinical Research Center include state-of-the-art information systems management – for datamanagement in both clinical care and clinicalresearch.

The Clinical Center has hired a Chief InformationOfficer and has reorganized the InformationSystems staff into two departments – theDepartment of Network Applications (DNA) andthe Department of Clinical Research Informatics(DCRI) – to meet organizational needs. The leader-ship of DCRI is charged with the oversight of thedesign, procurement and implementation of thenew Clinical Research Information System (CRIS).This process is inherently collaborative, with CCand IC customers taking lead roles in advising theChief of DCRI. To date, the many customers haveagreed on a plan for replacing the existing MedicalInformation System with a new CRIS backboneand have agreed to a long-term business plan creat-ed with substantive customer input. An integratedlaboratory system that has an interface to the exist-ing Medical Information System was also broughtonline during the past two years, substantiallyimproving the information management inLaboratory Medicine, Transfusion Medicine, andAnatomic Pathology (NCI).

The public learns about medicine, medical progress,and medical misadventures from the lay press.

The American public receives a great deal of its infor-mation about medicine, medical progress, and med-ical and clinical research-related misadventures fromthe lay press. The press frequently focuses on unique,“newsworthy” numerators, while not necessarily pro-viding a denominator for perspective. Such storiesmay contribute to a general mistrust of medicine and,in the eyes of the American Association of MedicalColleges have fostered a general decrease in publicsupport for academic medicine. This increasing



presence of the press presents a challenge for theCC. The organization must develop techniques formaking certain that the breakthroughs and benefitsof the clinical research conducted at the CC receiveappropriate attention in the press.

Medicine has traditionally avoided efforts intended tostandardize its practice.

The fact that medicine has attempted to maintainitself as an “art” rather than a science has led to widevariation in the ways in which physicians providecare for patients who have similar illnesses or simi-lar disease presentations. Pioneering studies evaluat-ing medical systems and processes have document-ed substantial variation in care delivered to patientswith similar syndromes and similar severity. Thesestudies and the burgeoning interest in “processimprovement” have resulted in an increasing focuson the systems and processes of medicine. Thisfocus has also produced a heightened level of inter-est in the design and conduct of behavioral, clinicaleffectiveness, and cost effectiveness studies. Drivenby cost concerns, the “outcomes” of various carestrategies have become increasingly important.Most “outcomes” analyses are based on scientificallysound epidemiological principles. For this reason,the CC is strategically positioned to assess a varietyof outcomes (e.g., physiologic, symptomatic, func-tional, perceptual, economic, and societal) in itsongoing natural history and disease pathogenesisstudies, as well as in clinical trials. Including assess-ment of these kinds of outcomes will help make thebasic and translational science products of the CC’swork relevant to medicine today.

The value of assessing the extent to which clinicalresearch practices are standardized has become evi-dent in the CC’s clinical research environment. Atthe NIH level, the standardization of clinicalresearch practices has been a major focus of theClinical Research Revitalization Committee. Asnoted above, the CC has embarked on an initiativeto “map” all the active clinical research protocols –both to determine the resources needed to supportthese studies as well as to track the extent to whichthe studies are proceeding as planned. In addition,Congress has mandated that NIH invest more inthe area of “health-services” and/or medical “out-comes” research.

As medicine moves toward primary care, interest insubspecialty and clinical research careers is decreasing.

One effect of the shift toward primary care is thatfewer high-quality young physicians are expressinginterest in subspecialty training and in careers inbasic or translational research. Thus, clinical pro-grams find fewer qualified individuals in fellowshippools. Some training programs have closed; othershave downsized significantly; others have moved toa purely clinical focus. Because of the continuallydecreasing candidate pool, attracting the best andthe brightest at the postdoctoral fellow level fromwithin the U.S. has become increasingly difficult forthe intramural program. This problem is undoubt-edly complex, involving heavy medical school debtburden, a move toward primary clinical care, andthe incentive that academic centers have for keepingtheir best. With the costs of a medical educationnow easily exceeding $125,000, new graduatesoften simply cannot afford to take three to sevenadditional years’ training before they begin to repaytheir debts. This challenge provides the CC and theNIH intramural program with the opportunity toaddress some of the financial concerns of new grad-uates as an incentive to coming to the intramuralprogram. NIH has attempted to address this prob-lem through the creation of three separate loanrepayment programs (AIDS, General, and ClinicalResearch). These programs have become valuablerecruitment and retention tools.

A traditional strength of the intramural program hasbeen that the international reputation of the NIHleads to international collaborations and attractsmotivated and gifted postdoctoral fellows from theinternational scientific community. These fellowswork in NIH programs, supporting the NIH mis-sion. Their work at NIH, in turn, facilitates thedevelopment of their careers when they return totheir respective countries.

The shift toward primary care has also resulted in anoverabundance of physicians in some specialties andsubspecialties. This relative surplus has resulted influctuations in academic salaries, particularly forsome historically highly paid specialties such as radi-ology and anesthesiology.


Government-Based External Factors

The Federal Government has reiterated an interest indownsizing and outsourcing. The President has issuedfive major goals for reforming management in govern-ment.

Each year, primarily as a consequence of the pene-tration of managed care in the healthcare market-place, in order to compete, academic centers havefewer dollars available for clinical research. Similarly,Federal agencies are responding to five goals of thenew administration. Outsourcing and privatizationare frequent considerations. Privatization representsone mechanism that can be used to make govern-ment smaller, more efficient, and more responsive tocustomers’ needs. Public/private partnerships havebecome increasingly common.

During the previous administration, the DHHSSecretary granted numerous delegations of authori-ty for personnel, procurement, and logistics thathave been frequently requested by the NIH com-munity. Perhaps paramount among these delega-tions of authority are new personnel/appointmentmechanisms (e.g., Title 38, Title 42) that permit theCC to pay highly competitive salaries to physicians,nurses, and allied health professionals that previous-ly would have been impossible under standard Title5, General Schedule pay authorities. The combina-tion of fluctuating salaries for some medical special-ties because of market pressure (discussed above)plus the remarkable flexibility of these new person-nel authorities has made it possible for the CC toassimilate contracts that were previously necessaryto provide adequate medical coverage for CCpatients. For example, the CC had previously beenunable to pay salaries that were competitive withthose at academic medical centers for radiologistsand anesthesiologists. These services, therefore, werecontracted out. The new pay authorities made itpossible for the CC to assimilate the radiology con-tract (projected annual savings in excess of 1.2 mil-lion dollars) and the anesthesiology contract (annu-al savings of up to 1.2 million dollars). The CC hascontinued to seek additional organizational efficien-cies. During FY2001-2002, the CC assimilated thelast eight positions from a longstanding (and for-merly quite large) contract supporting the ImagingSciences Program.

The new administration has reiterated an interest ingovernment wide-management reforms and hasestablished five major management reform goals:

1. Budget and Performance Integration: TheOffice of Management and Budget (OMB)vision is to provide a greater focus on organiza-tional performance, by formally integratingperformance/outcomes with budget decisions.The ultimate intent is to have agencies produceperformance-based budgets beginning inFY2003. The linkage of performance/outcomeswith budget will be phased in, with OMB ini-tially working with agencies to identify out-comes for a few programs, and to determinehow effectiveness can be improved.

2. Strategic Management of Human Capital:The President has proposed making the gov-ernment more citizen centered (i.e., ensuring aslittle distance as is possible between the citizensand decision makers). Two approaches will beused to address this goal: flattening or stream-lining the federal hierarchy, (i.e., reducing thenumber of layers), and using workforce plan-ning to help agencies redistribute higher-levelpositions to front-line, service delivery posi-tions that interact with citizens.

3. Competitive Sourcing: The President has pro-posed to increase competition for activities per-formed by the government as listed on agencyFAIR Act inventories, beginning with a require-ment in FY2003 that agencies complete public-private or direct conversion competitionsinvolving 10 percent of the FTE listed on theirFederal Activities Inventory Reform Act inven-tories over that competed to meet the FY2002competition goal. NIH will submit implemen-tation plans for achieving this goal and the CCwill be required to participate in these stream-lining activities.

4. Improving Financial Performance: The pri-mary goal of this initiative is to reduce erro-neous payments.

5. Expanding Electronic Government: ThePresident wants a coordinated approach to E-government that crosses agency boundaries.Specifically, the administration wants to: 1) prioritize and manage E-government proj-ects effectively by improving IT capital plan-ning; 2) create a citizen-centered web presenceand build E-government infrastructures thatinclude E-procurement and e-grants; and 3)develop an E-government approach that is per-

formance/ outcomes oriented (and includesspecific goals). To accomplish this goal: 1) agencies will be required to identify infor-mation technology investments that can beredirected or restructured; 2) agencies shouldmaximize the use of electronic means to deliverservices and benefits in a citizen-centric matter,while assuring both security and privacy.

Regulatory requirements are becoming more stringentand more burdensome.

Requirements of organizations that regulate the con-duct of patient care and clinical research in the CChave increased substantially over the past twodecades, in many instances without clearly addingvalue. Some oversight and regulatory activities arisefrom within NIH (e.g., Office of Human SubjectsResearch, Recombinant DNA Advisory Committee,Office of Scientific Integrity); others arise from ICprograms (e.g., Cancer Treatment EvaluationProgram, NCI); others arise from governmentalagencies/departments (e.g., Inspector General, Foodand Drug Administration) or organizations (e.g.,Nuclear Regulatory Commission, OccupationalSafety and Health Administration), and still othersarise out of a continuing need for external evaluationand accreditation of clinical activities (e.g., JointCommission on Accreditation of HealthcareOrganizations [JCAHO], College of AmericanPathologists [CAP], American Association of BloodBanks [AABB]). The CC faces the challenge of meet-ing the increasing requirements of a burgeoning listof regulators with decreasing staff, decreasingresources, and a physical plant that is in dire need ofrevitalization. Simultaneously, the CC has the oppor-tunity to consolidate certain of these activities (e.g.,the AABB or CAP surveys now substitute for bothcertification by the Centers for Medicare & MedicaidServices for the Clinical Laboratory ImprovementAct of 1988 [CLIA] and [JCAHO] surveys), and therequirements of some others provide justification forthe renewal of the CC.

In light of the increasing activity in the area ofmolecular medicine and the virtual explosion ofnew laboratory tests that can be used for diagnosisand prognosis in medicine, the CC, and, in fact, theentire NIH has come under increasing pressure tohave its laboratories comply with CLIA. The CCDirector has been given the task of ensuring that allintramural laboratories performing laboratory testslinked to patient identifiers that may be used inpatient care meet CLIA standards. To establish the

processes, to perform the internal proficiency tests,and to maintain the records necessary to complywith CLIA, will likely be viewed as substantial reg-ulatory burden by NIH investigators.

Agency (NIH)-Based External Factors

As a result of a constellation of factors, the culture of theNIH Intramural program is changing.

Several factors, taken together, have produced, andare continuing to produce, a substantial change inthe environment and culture of the NIH Intramuralprogram. Among these factors are the following:

• NIH and IC administrators have made a majorinvestment in scientific quality. Several ICshave conducted detailed external reviews oftheir intramural programs in the past 60months. In addition, an external panel con-vened by the NIH Director (i.e., theMarks/Cassel Committee) issued a detailedreport that provided clear recommendations torevitalize the intramural program.20

• NIH has developed and implemented a new,more rigorous tenure-track and tenuring policy.

• The rigor of scientific reviews has been intensi-fied.

• The NIH Director, and several intramural sci-entists have made a major effort to elevate thestatus of clinical research on the NIH campus.The net effect from these leadership efforts hasbeen that several institutes have initiated newprograms and/or recruited new clinical investi-gators to buttress their clinical research activi-ties. The CC has developed a proactive strategyfor managing new programs and significantprogram expansions that includes biweeklymeetings with all IC and CC stakeholders, thecreation of an implementation plan, and ongo-ing follow-up with IC leadership and staff toassure smooth implementation.

• As technology advances, institutes are increas-ingly requesting more, and more sophisticated,clinical research support. During institute plan-ning meetings for the past two years, an increas-ing number of requests for clinical research sup-port activities (as opposed to standard care sup-port) have been received. The CC needs todevelop a process for deciding (in concert with


its collegium of customers) which of therequests to implement, as well as how to presentthe increased costs associated with these projectsto both internal and external customers. Suchservices (which are often both efficiently andeffectively centralized) add substantially to theexpense of running the CC. One example ofsuch a service is the CC’s Clinical Epidemiologyand Biostatistics Service. This service, initiallyestablished to meet the needs of CC investiga-tors, has been expanded to meet the needs ofsome institute investigators. Some institutes thatlack adequate biostatistics and study design sup-port have been willing to fund part or all of afull time employee to allow their investigatorsaccess to the service.

• The costs associated with conduct of biomed-ical research are escalating faster than inflation,necessitating that Institutes carefully evaluatecosts and quality of proposed intramural proj-ects with more rigor than has been done in thepast.

• A variety of factors have conspired to producean unprecedented level of trans-IC collabora-tion and sharing of resources, among them:

• Increased emphasis on clinical research and onresearch quality on the NIH campus;

• Increasing costs of clinical research;

• Increased reliance on molecular methods,genomics, proteomics, and specific expertise,not necessarily associated with an IC or a disci-pline to conduct complex studies;

• Increased emphasis by CC and NIH leadershipon planning;

• Emphasis on the part of CC leadership on theinclusion of major customers, partners andstakeholders in the planning process; and

• Joint CC/IC appointments in Imaging Sciences,Bioethics, and Clinical Pharmacology.

• The construction of the new Clinical ResearchCenter, which will not be organized with dedi-cated “Institute-space,” has fostered collabora-tion among the partners who will share spaceand resources in the new building. The newbuilding and the change in clinical and admin-

istrative governance in patient care presents theCC with a unique opportunity for the organi-zation to reassess the processes that it uses toprovide care and affords the opportunity toredesign some of these processes to improvepatient care quality and/or efficiency.

• During the past two years a new funding streamhas been established for the CC. This fundingmechanism is influencing IC stakeholders to bol-ster their clinical research programs and has like-ly contributed to increasing use of the CC. ICspay a “school tax” based directly on the size of theICs’ intramural appropriation to support the CC(without regard to the extent to which the IC usesthe facility); the disincentive to use the CC (inthe previous funding scheme) has been replacedwith an incentive to use it. This approach alsosolves the problem identified by the SmitsCommittee of the interdependence of the ICs’budgets under the prior funding structure.

• The Board of Governors oversight of CC oper-ations lessens the extent to which the CC musttry to respond to the competing priorities of itsIC customers. This increased independenceshould permit the CC to become more efficientand to foster collaboration among the ICs con-ducting research in the CC.

The NIH budget receives intense scrutiny by Congressand the President.

Twenty-five years ago the costs of clinical researchwere not a primary concern of the ICs conductingresearch in the CC. In the late 1980s and early1990s, however, the increases in the costs of clinicalresearch in the CC began to rise significantly fasterthan the overall intramural budget. Almost simulta-neously, the ICs became aware of the substantial dif-ferences in the costs of clinical versus benchresearch. Some ICs began to divest themselves oftheir clinical research portfolios in order to cut costs.When the current CC Director was appointed, hemade financial stewardship and increased financialaccountability a primary goal for the organization.New planning mechanisms, new information sys-tems, and new reports of utilization were developedto provide more and more accurate information tothe ICs. Even in the year 2001, however, the CCstill faces the challenge of overcoming a reputation,developed from 1950 through the 1970s, of notbeing cost conscious.


In the past several years, both the Congress and thePresident have publicly stated a goal of doubling theNIH budget. Thus, NIH and the CC have receivedsubstantial budget increases for the past severalyears. The process of doubling the NIH budget willbe completed in 2003, and NIH leadership believesthat subsequent years may not see such robustincreases in funding. Given that certain hospitalcosts (e.g., pharmaceutical and soft goods inflation)will continue to escalate at a rate that far exceedsintramural budget growth, CC leadership and man-agers need to plan now for leaner times in thefuture. The next two years provide the CC with anexcellent opportunity to identify organizational effi-ciencies, develop cost-consciousness and to developinnovative approaches to care and clinical researchdelivery to allow the CC to remain financiallysound within the budget that NIH gives to theorganization. The CC has taken several approachesto increasing its organizational efficiency, includingthe assimilation of expensive contracts, the institu-tion of operational reviews for CC departments,and increasing reliance on the CC Board ofGovernors who have substantial expertise in health-care operations.20 The Board, which includesnumerous healthcare executives from prestigiousextramural academic centers, provides advice to theCC Director concerning CC operations. The mod-ified governance structure and the Board ofGovernors have provided CC leadership with theopportunity to manage the operations of the organ-ization more efficiently than ever before.

IC research agendas compete directly with each other;for NIH to improve overall corporate efficiency, collab-oration among ICs is essential.

Occasionally, IC research agendas compete direct-ly with each other. Although NIH efforts havebeen expended over the past several years toattempt to facilitate trans-IC collaboration,because of the highly competitive nature of someareas of investigation, collaboration has sometimesproven difficult to achieve. Because ICs competefor CC resources while independently valuingwidely disparate services, the CC is faced with thechallenge of meeting these varied requirementswhile fostering collaboration and cooperationamong IC scientists in a cost-competitive environ-ment. In addition, the CC is faced with the chal-lenge of integrating basic science and basic scien-tists into the clinical research agenda of the NIHintramural program. Since many basic scientistsare unaware of the opportunities and venues in

which to apply basic science findings, the CC isfaced with the challenge of improving the accessi-bility of the CC and its resources to basic scientists.

As noted above, collaboration among ICs becomesincreasingly important as the new ClinicalResearch Center is being planned. ICs will not‘own’ clinical space in the new building, but willshare space in clinical programs. Since the designof the new building will not be institute or centerbased, but rather based on clinical disciplines orprograms of care, ICs will be required to sharespace and resources in the new facility. The natureof modern molecular medicine calls for morecross-IC collaboration. The CC and IC stakehold-ers worked together to form groups of partnersamong the ICs that will be sharing space andresources in the new facility. These groups of part-ners have increased the quality of the planningeffort substantially.

NIH has endorsed a change in governance for the CC.

The creation of the CC’s Board of Governors pro-vided the CC with the unique opportunity to createa governance structure that can prepare the organi-zation to compete effectively in the clinical researcharena for the foreseeable future. The new gover-nance structure has permitted the following uniqueopportunities for CC management:

• The opportunity to seek the expert advice con-cerning hospital operations and managementfrom nationally recognized authorities in hospi-tal and research management;

• The opportunity to manage the clinicalresearch process more efficiently than under theprior system;

• The opportunity to facilitate change far moreefficiently than under the prior system; and

• The opportunity to seek and develop organiza-tional flexibilities not possible under the exist-ing system (e.g., delegations of authorities,generic clearance for surveys, etc.).



1. Gallin JI, Smits HL. “Managing the interface betweenmedical schools, hospitals, and clinical research.” JAMA1997; 277(8): 651-4.

2. Report of the External Advisory Committee of the NIHDirector’s Advisory Committee, a report of the NationalInstitutes of Health Intramural Research Program,November 17, 1994, U.S. Department of Health andHuman Services, p 32.

3. Report of the External Advisory Committee, p 33.

4. Gallin JI, Varmus H. “Revitalization of the Warren GrantMagnuson Clinical Center at the National Institutes ofHealth.” Acad Med 1998; 73(5): 460-6.

5. “Opportunity: Revitalizing the NIH Clinical Center fortomorrow’s challenges: a report from the DHHS REGOII Options Team,” p 1-2.

6. DHHS REGO II Options Team report, p 4-1.




10. DHHS REGO II Options Team report, ExecutiveSummary, p v.











Bibliography

Strategic Plan Environmental Assessment - NIH Clinical … · Strategic Plan Environmental Assessment ... and fiscal manage- ... • The new building has also served as a stimulus

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