Clinical Research Information System (EHR/CR) – Functional Profile HL7 Working Group EHR-S Technical Committee Presentation.

Clinical Research Clinical Research Information System Information System

(EHR/CR) – Functional (EHR/CR) – Functional ProfileProfile

HL7 Working GroupHL7 Working Group

EHR-S Technical CommitteeEHR-S Technical Committee

PresentationPresentation

AgendaAgenda

EHR/CR-FP Working GroupEHR/CR-FP Working Group Team MembersTeam Members eHealth (EHR) eHealth (EHR) Business Realities of Drug Business Realities of Drug

DevelopmentDevelopment The Challenge The Challenge The ProfileThe Profile

EHR/CR-FP Working GroupEHR/CR-FP Working Group

Organized by the eClinical Forum and Organized by the eClinical Forum and PhRMA EDC/eSource Task Force.PhRMA EDC/eSource Task Force.

International Representation International Representation

Collaborative effort between bio-Collaborative effort between bio-pharmaceutical and healthcare pharmaceutical and healthcare industries and associated vendorsindustries and associated vendors

EHR/CR-FP Co-chairsJohn D. Mestler Procter & Gamble PharmaceuticalsSuzanne Bishop SKB Consulting

EHR/CR-FP Functional Profile Working Group (International Group)Seema Bhat BayerPaul Brandon Siemens Medical SolutionsRobert Case Procter & Gamble PharmaceuticalsCatherine Celingant Millennium PharmaceuticalsGary Drucker BayerPatricia Gregory Boehringer IngelheimJane Griffin Cerner CorporationIan Hamilton Eli LillyDarlene Kalinowski Bristol Myers SquibLinda King Eli LillyMarie MacDonald ClinPhoneRichard Perkins Concept ConsultingMathias Poensgen Altana PharmaceuticalsChristian Reich Millennium PharmaceuticalsVincente Rodriguez Eli LillyMiguel Valenzuela Roche

eHealth is Driven by the need eHealth is Driven by the need to…to…

Bringing information and knowledge to the Bringing information and knowledge to the point of carepoint of care

Realizing this across boundariesRealizing this across boundaries

Moving from specialist-centric to patient-Moving from specialist-centric to patient-centric informationcentric information

Enhance patient safetyEnhance patient safety

Improve quality of healthcareImprove quality of healthcare

Reduce healthcare costsReduce healthcare costs

eHealth is About…eHealth is About…

Business Realities of Business Realities of Drug DevelopmentDrug Development

The FactsThe Facts Innovation of medicines Innovation of medicines

is a high-risk businessis a high-risk businessLess than 9% of clinical Less than 9% of clinical candidates make it to candidates make it to patientspatients

The cost and timescale of The cost and timescale of innovative medicine has innovative medicine has escalatedescalated

A new molecule can cost A new molecule can cost $750M -$1.0B and takes $750M -$1.0B and takes 11-15 years to develop11-15 years to develop

Research $ focused Research $ focused where there is a ROIwhere there is a ROI

The ResultsThe Results Failure to innovate is leading to Failure to innovate is leading to

fewer new innovative medicines fewer new innovative medicines reaching the patientreaching the patient

Failure to control cost and move Failure to control cost and move fast enough is leading to more fast enough is leading to more expensive and late therapiesexpensive and late therapies

Potential medicines not Potential medicines not reaching the patient and niche reaching the patient and niche markets of high medical need markets of high medical need not being explorednot being explored

Electronic Data Capture (EDC)Electronic Data Capture (EDC)

Reporting

DATA

ATADATA

DATA

ATADATA

CDMS

SiteEDC

Web Server

Subject

Paper

ePROWeb

Server

Labs

Archive &

Submission

ECG

Source

ePRO

The Challenge … The Challenge … Patient Patient

visitvisitPaper Paper

Medical Medical RecordRecord

Paper or Paper or Electronic Electronic

Medical Medical RecordRecord

Paper Paper CRFCRF

EHR-SEHR-S

TrialTrial

Future Future Integration Integration

Approaches To Clinical Trial Data Capture At Investigator Sites

Research Research DatabaseDatabase

Electronic Electronic CRF, ePRO, CRF, ePRO,

LabsLabs

Research Research DatabaseDatabase

Research Research DatabaseDatabase

Emerging but Emerging but Duplicative Duplicative

HistoricalHistorical

Hosted Hosted DataData

HealthcareHealthcare ResearchResearch

EDCEDC

Trial Trial Specific Specific

DataData

Electronic Electronic Health Health RecordRecord

With the increased use of EHR / EMR, the Emerging EDC Environment With the increased use of EHR / EMR, the Emerging EDC Environment Results In… increased effort, cost, possibility of questionable Results In… increased effort, cost, possibility of questionable authenticityauthenticity

The Challenges …The Challenges …

Results In… Results In… Minimized effort Minimized effort

and cost, better data and cost, better data quality, improved drugquality, improved drug

safety,safety, greater research greater research opportunityopportunity

ProcessControlled process for release and transfer of data meets bio-ethical

concerns

Future Connected

Healthcare & Research

StandardsCommon data

standards allow movement of data

between healthcare and research

SystemsReliable, validated

systems meet healthcare and

research requirements

EHR/CR Profile DescriptionEHR/CR Profile Description Establishes requirements, non-redundant functions, Establishes requirements, non-redundant functions,

processes to use patient electronic medical data for clinical processes to use patient electronic medical data for clinical research.research.

Ensures that data protection, regulatory, and ethical Ensures that data protection, regulatory, and ethical research requirements are met.research requirements are met.

MinimizeMinimizess the challenges of clinical research for healthcare the challenges of clinical research for healthcare professionals. professionals.

Endorses data standards (CDISC/HL7) for data collection, Endorses data standards (CDISC/HL7) for data collection, interpretation and exchange within the medical and interpretation and exchange within the medical and research communities.research communities.

Expand and adapt functions of EHR and the associated Expand and adapt functions of EHR and the associated systems, networks, and processessystems, networks, and processes

Profile ObjectiveProfile Objective Develop an HL7 Informative Functional Profile that identifies Develop an HL7 Informative Functional Profile that identifies

critical capabilities for clinical research utilizing EHR systems.critical capabilities for clinical research utilizing EHR systems.

Establish conformance to the HL7 EHR Functional Model, under the Establish conformance to the HL7 EHR Functional Model, under the auspices and direction of the EHR Technical Committee. auspices and direction of the EHR Technical Committee.

Provide EHR vendors conformance criteria that are specific to Provide EHR vendors conformance criteria that are specific to Clinical Research.Clinical Research.

Encourage incorporation of the functions necessary to utilize the Encourage incorporation of the functions necessary to utilize the Electronic Health Records as the direct data source for clinical Electronic Health Records as the direct data source for clinical studies. studies.

Define additional functions that may be required and have not yet Define additional functions that may be required and have not yet been included within existing functional models.been included within existing functional models.

International ProfileInternational Profile

Profile PhasesProfile PhasesThe project is planned in four phases:The project is planned in four phases:

OrganizationOrganization

• participants, determination of participants, determination of • scope scope • care settingcare setting• Project Plan Project Plan

FormalizationFormalization –EHR/CR-FP functions and conformance –EHR/CR-FP functions and conformance criteria criteria (in process)(in process) . .

HarmonizationHarmonization – comparison, incorporation, and alignment – comparison, incorporation, and alignment with the EHR FM with the EHR FM (in process)(in process) . .

FinalizationFinalization – Conformance and preparation for final EHR – – Conformance and preparation for final EHR – TC approval and external publication.TC approval and external publication.

Profile – Essential Now (EN)Profile – Essential Now (EN)

Ensure that patient data from an EHR system will Ensure that patient data from an EHR system will meet clinical research regulatory requirements meet clinical research regulatory requirements for data collection, management, extraction, for data collection, management, extraction, security, and can be interpreted in a consistent security, and can be interpreted in a consistent manner.manner.

Functions must be present to use EHR data for Functions must be present to use EHR data for clinical research without redundant re-keying and clinical research without redundant re-keying and verifying verifying

Note: If we can think of a reasonable work-around Note: If we can think of a reasonable work-around we can move function into the essential futurewe can move function into the essential future

Profile – Essential FutureProfile – Essential Future

Functions needed to improve efficiency and Functions needed to improve efficiency and performanceperformance

Functions necessary to ultimately conduct all Functions necessary to ultimately conduct all clinical research data capture and management clinical research data capture and management through nation-wide health information networks through nation-wide health information networks and systems. and systems.

Functions will be divided into levels along the Functions will be divided into levels along the evolution to this ultimate goal. None of the EF evolution to this ultimate goal. None of the EF functions will be required to be present on “day functions will be required to be present on “day 1” of using the EHR data for clinical research. 1” of using the EHR data for clinical research.

(Sponsors can provide work-arounds either (Sponsors can provide work-arounds either through processes or sponsor-supplied electronic through processes or sponsor-supplied electronic systems). systems).

Profile – Essential FutureProfile – Essential Future

Examples of Possible Future FunctionsExamples of Possible Future Functions The function should support data The function should support data

checking (i.e., for reasonableness as checking (i.e., for reasonableness as defined by the trial sponsor) defined by the trial sponsor)

Electronic signature capability in Electronic signature capability in compliance with Part 11compliance with Part 11