EMRs for Clinical Research: Hype versus Reality

Edward S. SeguineCEOClinical Ink

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Discussion Points• Industry Metrics

• BMS Operational Perspective

• FDA Regulatory Viewpoint

• Novartis Experience

• Recent Industry Activity

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EMRs for Clinical Research?

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Poll: How much was spent on Phase 1-3 Clinical...

Poll #1

Poll #1

How much was spent on Phase 1-3 clinical trials last year?

$40 BILLION$1,200,000 for EVERY employee

involved in clinical trials

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Source: Medidata CRO Contractor Fact Sheet; June 2012

Total Clinical Trial Costs

29%

26%

18%

12%

6%5% 4%

Monitoring Spend

R&D Spend Monitoring

Phase 1 $5.6B $1.2B

Phase 2 $8.8B $2.7B

Phase 3 $25.4B $7.9B

TOTAL $39.8B $11.8BSource: 2012 PhRMA Industry Report

UNSUSTAINABLE!

Poll: EMRs will replace EDC for eSource in:

Poll #3

EMRs for “Research”

• Applied Clinical Trials Survey:

71% EHR/EDC will merge within 5 years

February 1, 2007

“The possibility of performing a clinical trial with data extracted directly from EHRs was highly impractical and would not likely enter routine use for 15 to 20 years. I now recognize that I significantly underestimated the difficulties.”

Paul Bleicher, DIA Global Forum, Dec 2010

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EMR CertificationCertification Commission for Health

Information Technology (www.cchit.org)

Published EMR functionality standards for clinical research in 2011

80 Certified EMRs

Poll: What % of EMRs are certified for Clinica...

Poll #3

EMR CertificationCertification Commission for Health

Information Technology (www.cchit.org)

Published EMR functionality standards for clinical research in 2011

80 Certified EMRs

0 for Clinical Research

EMR FunctionalityElectronic Health Records for Clinical

Research (www.ehrcr.org)

Practical Considerations for Sites using EHRs Certified for Clinical Research

74 Pages

User Requirements

Functional Profile (IHE, HL7)

EMR FunctionalityCDASH

Demog, AE, MedHx, ConMed, Physical Exam, VitalsUse of RFD Profile to exchange data with EDC

Capture Audit Trail

Generate PDFs

Password and LogIn Rules

Backup and Recovery

EMR NON-Functionality

HITSP RFD Profile (CAP135)20 of 37 Requirements DO NOT EXIST

CCHIT Certification19 or 35 Requirements DO NOT EXIST

HUGE GAPS

EMR Data QualityComprehensive Literature Review (35 studies)

- Disparity in granularity, format, optional locations, and structure of data

- Accuracy and Completeness differ for Acute versus Chronic conditions

- Medication lists particularly error-prone due to discontinuations

- Lab data the most accurate and complete

- Focus on large academic institutions

1“Electronic Health Records and the Reliability and Validity of Quality Measures”, Medical Care Research and Review, February 2010

EMR Data AvailabilityUniversity of Colorado – Childrens Hospital

1,093 CRF data elements; 47% in the EMR

1“Electronic Health Records and the Reliability and Validity of Quality Measures”, Medical Care Research and Review, February 2010

Data Type % Available in EMR

% of Total Study

Laboratory Tests 100% 18%

Demographics 98% 8%

Medications 74% 9%

Medical History 54% 18%

Trial Diagnostics 21% 19%

Questionairres 0% 28%

Myth of EMR as eSource

EMRs can’t be “ultimate” eSource goal– Viable when trial data is standard of care

– Limited data (demographics, labs, MedHx)

– Unaware of protocol specific requirements

– Inflexible systems – access, audit trail

– Discrepancy between CODING and DISEASE

– Twenty years of experience in the UK?

– Business value is reduced monitoring not data exchange

– 65% of sites are stand-alone practices

Secondary Use of EMRs• Preliminary site identification based on patient

pools

• Reporting of Adverse Events

• Impact of inclusion/exclusion criteria on trial enrollment

BUT, these benefits only accrue IF the EHR data is captured consistently across institutions.

EMRs for Clinical Research?