NIH Future Directions

NIH Future DirectionsNIH Future Directions

Craig J. McClain, M.D., ProfessorCraig J. McClain, M.D., Professor

Division of Gastroenterology/HepatologyDivision of Gastroenterology/Hepatology

Departments of Medicine, Pharmacology and Departments of Medicine, Pharmacology and ToxicologyToxicology

University of Louisville University of Louisville

Louisville VA Medical Center Louisville VA Medical Center

ObjectivesObjectives

NIH FinancesNIH Finances

NIH trends, changesNIH trends, changes

Update on CTSAsUpdate on CTSAs

Challenges for UofL CTSA, LICTS Challenges for UofL CTSA, LICTS and U of L Researchand U of L Research

NIH Budget: What Is Really Happening?NIH Budget: What Is Really Happening?

Universities

Flat-line budget

Major NIH funding loss

“What we have here is a failure to communicate”

Cool Hand Luke

Politics & Economics: Law Shifts NIH Balance of Power Patient Groups Fear For Their Research As Funds Are Pooled By Bernard Wysocki Jr., The Wall Street Journal, Jan 31, 2007 Congress has strengthened Dr. [Elias Zerhouni]'s hand considerably. As part of a bill passed in December's lame-duck session, Dr. Zerhouni and his successors will be able to organize a "common fund" designed eventually to pool about 5% of the NIH's money. That is $1.5 billion a year at today's levels. The idea is to pour funding into research projects that cut across traditional biomedical fields and across multiple NIH fiefs. The new program addresses some of Congress's concerns that the NIH is big, slow and can't innovate.

1998 1999 2000 2001 2002 2003 2004 2005 2006 20070

5

10

15

20

25

30

35

NIH ($billions)

$ (Billions)

NIH Congressional AppropriationsNIH Congressional Appropriations

Doubling

00

1010

2020

3030

4040

5050

6060

7070

8080

UofL ($millions)UofL ($millions)

$ (M

illio

ns)

$ (M

illio

ns)

As Many New As Many New ApplicantsApplicants in the in the Last 2 yearsLast 2 years as during the previous 5 years! as during the previous 5 years!

≈≈

26583 - 21249

(2003) – (1999)Period of doubling

5334

31791 - 26583

(2005) – (2003)

5208

UofL/UK NIH FundingUofL/UK NIH Funding

0102030405060708090

NIH

Do

llars

Millions

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

UK

UofL

Source: NIH OER database

UofL Programs of DistinctionUofL Programs of Distinction

0 5 10 15 20

Neurosciences

Birth Defects

Oncology

Cardiovascular

Millions of Dollars ($)

2005

2000

Growth of R21 Applications Reviewed at CSR vs. Other ICs

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

2001 2002 2003 2004 2005 2006

CSR Other

Growth of R01 Applications Reviewed at CSR vs. Other ICs

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

2001 2002 2003 2004 2005 2006

CSR Other

Number of NIH Number of NIH KK Awards Awards

GOOD NEWS

1,500

2,000

2,500

3,000

3,500

4,000

4,500

1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Fiscal Year

Nu

mb

er

NIH GoalNIH Goal

Fund training awardsFund training awards

Keep the pipeline openKeep the pipeline open

TEST – What is “correct” TEST – What is “correct” first grant?first grant?

36 year old new MD faculty 36 year old new MD faculty membermember–RO3RO3–R21R21–RO1RO1–K23K23–K12K12

NIH NIH Trends/InnovationsTrends/Innovations

Major Complaints About NIH Major Complaints About NIH Peer ReviewPeer Review

The process is too slowThe process is too slow

There are not enough senior/experienced reviewersThere are not enough senior/experienced reviewers

The process favors predictable research instead of The process favors predictable research instead of significant, innovative, or transformative researchsignificant, innovative, or transformative research

Clinical research may not fare as well as other Clinical research may not fare as well as other researchresearch

The time and effort required to write, submit, resubmit, The time and effort required to write, submit, resubmit, review and re-review is a heavy burden on applicants review and re-review is a heavy burden on applicants and reviewersand reviewers

Updated Oct. 4, 2006

Electronic SubmissionElectronic SubmissionTransition TimelineTransition Timeline

Electronic SubmissionElectronic SubmissionNew dates prevent “submission overload”New dates prevent “submission overload”Most submissions not on 1Most submissions not on 1stst of month of monthNIH contributes only about ½ of NIH contributes only about ½ of submissionssubmissionsFeb 5, 2007 – about 4,000 RO1sFeb 5, 2007 – about 4,000 RO1s82% error-free on 182% error-free on 1stst attempt attempteRA Commons record 19,283 logins on eRA Commons record 19,283 logins on Feb 5, 2007Feb 5, 2007

Shorter ApplicationShorter ApplicationProbably ~15 pagesProbably ~15 pages

Many other grants shorterMany other grants shorter– Canada, VA, DODCanada, VA, DOD

NIH Guide Survey on Shorter R01 ApplicationsNIH Guide Survey on Shorter R01 Applications

Responses Responses NumberNumber PercentPercent

For Shorter ApplicationsFor Shorter Applications 2,3572,357 74%74%

Against Shorter ApplicationsAgainst Shorter Applications 846846 26%26%

TotalTotal 3,2033,203 100%100%

Reviewer Crisis Reviewer Crisis

Far too many reviewers on study Far too many reviewers on study sectionssections

Too many ad hoc reviewersToo many ad hoc reviewers

Not enough “senior” reviewersNot enough “senior” reviewers

Almost 80,000 grants – lots of work!Almost 80,000 grants – lots of work!

~ 20,000 reviewers~ 20,000 reviewers

The First NIH The First NIH Study Section Study Section

19461946

The Last NIH The Last NIH Study Section Study Section

20062006

Smaller LargerOlder YoungerReviewed ~12 grants Review ~ 6 grants

Expanding Peer Review’s Expanding Peer Review’s PlatformsPlatforms

Electronic ReviewsElectronic Reviews

Telephone Enhanced DiscussionsTelephone Enhanced Discussions

Video Enhanced DiscussionsVideo Enhanced Discussions

Asynchronous Electronic DiscussionsAsynchronous Electronic Discussions

Study Sections

Our Goal: 10% of all reviews to be electronic in 2007

What It Looks Like: Video What It Looks Like: Video Enhanced DiscussionsEnhanced Discussions

What It Looks Like: What It Looks Like: Asynchronous Electronic DiscussionsAsynchronous Electronic Discussions

Shortened Review CycleShortened Review Cycle

NIH Pilot Study of New Investigator R01sNIH Pilot Study of New Investigator R01s

Who Benefits from Quick Review?Who Benefits from Quick Review?

- On “bubble” or close- On “bubble” or close

- Able to respond quickly with - Able to respond quickly with changes/new datachanges/new data

Only 13% in pilot study could do soOnly 13% in pilot study could do so

A Proposal for Deep Innovation A Proposal for Deep Innovation GrantsGrants

Short, 5-8 pagesShort, 5-8 pages

Focus on people, not payoffFocus on people, not payoff

Relevance separated from reviewRelevance separated from review

Ranking, not scoringRanking, not scoring

We’re not good predicting big advancesWe’re not good predicting big advances

Multiple PI InitiativeMultiple PI InitiativePrincipal Investigators (PIs) sometimes work in Principal Investigators (PIs) sometimes work in teamsteamsMany projects dependent on collaborationMany projects dependent on collaborationGrowing consensus that team science is Growing consensus that team science is discouraged by recognition of only one PI. discouraged by recognition of only one PI. Other Federal agencies have recognized co-PIs for Other Federal agencies have recognized co-PIs for years years

To avoid confusion, the term “Co-PI” will not To avoid confusion, the term “Co-PI” will not be used by NIHbe used by NIHThe application is the same as it would be for a The application is the same as it would be for a single PI, with the exception of an expanded list of single PI, with the exception of an expanded list of PIs and a PIs and a Leadership PlanLeadership Plan. .

Fiscal Year

Age

- Average MD age > 44

Average age of New Investigators at initial R01/R29 award

43.3

36.7

38.3

39.6

42.7 43.2

39.3 39.1 39.3

42.8

41.7

34.3

36.8

38.9

41.6

34

36

38

40

42

44

1970

1971

1972

1973

1974

1975

1976

1977

1978

1979

1980

1981

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

MD

MD-PhD

PhD

Linear (PhD)

Linear (MD)

NIH Peer Review of Grant NIH Peer Review of Grant ApplicationsApplications

for Clinical Researchfor Clinical ResearchKotchen, et al. JAMA 2004;291:836Kotchen, et al. JAMA 2004;291:836

Conclusion:Conclusion:– Although physicians compete favorably in the Although physicians compete favorably in the

peer review process, review outcomes are peer review process, review outcomes are modestly less favorable for grant applications modestly less favorable for grant applications for clinical research than for laboratory for clinical research than for laboratory research.research.

Automated Referral Workflow System

Referral MethodReferral Method PercentagePercentage

PI assignment request automatically PI assignment request automatically mined from cover lettermined from cover letter

4747

Machine learning prediction when no PI Machine learning prediction when no PI request and > 80% likelihood of request and > 80% likelihood of agreement with human expertsagreement with human experts

3939

Remainder referred by human expertsRemainder referred by human experts 1414

- How does my grant get to the right place?

Travel - savingsTravel - savings

Purchase non-refundable (restricted) coach Purchase non-refundable (restricted) coach tickets instead of unrestricted ticketstickets instead of unrestricted tickets

Preliminary Pilot Data – June to November Preliminary Pilot Data – June to November 20062006

# of tickets issued  # of tickets issued   9,1349,134

Changes requested Changes requested  658658

cost of changes + fees  cost of changes + fees   $175,321$175,321

YTD Fare SavingsYTD Fare Savings $4,742,251$4,742,251

Update on CTSAsUpdate on CTSAs

P20 applicationP20 application

Need better COBRE planningNeed better COBRE planning

Update on UofL CTSA, Update on UofL CTSA, LICTS, and UofL LICTS, and UofL

Research ChallengesResearch Challenges

University of Louisville ’s CTSA

President’s OfficePresident

Provost Executive VP for Research

Director, LICTS

Internal Advisory Committee-Deans-Hospitals-Others

LICTS Executive Committee-Community-Education-Biostatistics/Bioinformatics-Methologies/Resources-Pilots-Regulatory/Ethics

Director, Education

Community Biostatistics/Bioinformatics

Partners in Innovation Pilots Education

OutreachAHECTroverClinicHealth Depts.

Biostat. ConsultingBioinformaticsE-record

Drug developmentDevices

Studies Interdisciplinary MS/PhDTraining grantsCurriculum Dev.

External Advisory Committee

RegulatoryHospitalsFacilities/Cores Ethics

Executive VP for Health Affairs

Top priority of many institutionsTop priority of many institutions

UofL needs to evaluate goalsUofL needs to evaluate goals

CTSA/LICTS Challenges and CTSA/LICTS Challenges and GoalsGoals

Top 10 ListTop 10 List1. 1. University CTSA Goals—Need SummitUniversity CTSA Goals—Need Summit2. Institute Status2. Institute Status3. Director Position3. Director Position4. Space Issues—Short and Long Term4. Space Issues—Short and Long Term5.5. Education—Degree GrantingEducation—Degree Granting6.6. U of L Internal support for Education InitiativesU of L Internal support for Education Initiatives7.7. Be prepared to submit institutional grants, such as K12, Be prepared to submit institutional grants, such as K12,

K30, T32s, etc., and individual K, T, F grantsK30, T32s, etc., and individual K, T, F grants8.8. Research Partners (e.g., Humana, Jewish, Norton, Research Partners (e.g., Humana, Jewish, Norton,

Metacyte)Metacyte)9.9. Biostatistics/Bioinformatics supportBiostatistics/Bioinformatics support10. Budget/Financial Support10. Budget/Financial Support

Dave’s Top 10

Craig’s Top 10

University of Louisville Research Goals/IssuesUniversity of Louisville Research Goals/IssuesTop 10 ListTop 10 List

1. 1. University Mission/Goals/Long Range PlanUniversity Mission/Goals/Long Range Plan2. 2. Bridge FundingBridge Funding3. 3. Start-up FundsStart-up Funds4. 4. Limited Hospital SupportLimited Hospital Support5. 5. “Flat Line” NIH Budget“Flat Line” NIH Budget

● ● Understand NIH RoadmapUnderstand NIH Roadmap● ● Understand Changes at NIHUnderstand Changes at NIH

6. 6. Clinical Trials IssuesClinical Trials Issues● ● Identify it as a problem that needs to be fixedIdentify it as a problem that needs to be fixed

Contracting, Western IRB, Facility support—e.g., CRC,Contracting, Western IRB, Facility support—e.g., CRC,MalpracticeMalpractice

7. 7. Building Partnerships in Research (e.g., Humana) and including our local Building Partnerships in Research (e.g., Humana) and including our local community partners (e.g., Norton, Jewish, Kindred, West End, Louisville Metro community partners (e.g., Norton, Jewish, Kindred, West End, Louisville Metro Health Dept., etc.) and regional partners (e.g., AHEC)Health Dept., etc.) and regional partners (e.g., AHEC)

8.8. More HSC interactions with Belknap (Engineering, Business, Social Work, A&S, More HSC interactions with Belknap (Engineering, Business, Social Work, A&S, Graduate School,Education/Human Development)Graduate School,Education/Human Development)

9. 9. Better Use of Existing U of L Research Resources (decreased duplication, better Better Use of Existing U of L Research Resources (decreased duplication, better core use/support, core use/support, space plan)space plan)

10. Accessibility and Expansion of Biostatistics/Bioinformatics10. Accessibility and Expansion of Biostatistics/Bioinformatics

Dave’s Top 10

Craig’s Top 10