1. Healthcare Link Initiatives: Bridging Clinical Research and Healthcare May 29, 2008 Bay Area Users’ Group Landen Bain CDISC Liaison to Healthcare

2. 2 NIH / DCRI CDASHCDASH Data Collection Stds (FDA Critical Path) Integration Profile Healthcare Link Demo CV/ TB Data Stds Terminology WHO International Clinical Trial Registry Platform Submission Standards Protocol Representation Critical Path Initiative Liaison Status to ISO/TAG215 Submitted CDISC Standard as New Work Item Protocol Representation w/ elements mapped to EudraCT Discussing all CDISC projects BRIDG PhRMA EFPIA Shared Information Business Case CDASH IA Project eSubmissions

3. 3 Healthcare Link Relationships

4. 4 Circa 1998 ….. auto reconciliation data conception (e)CRFs (e)Source Documents EHR eSource Healthcare Delivery Clinical Research

5. 5 Patient Care World Clinical Research World Single Source 2003 An industry initiative that has successfully demonstrated clinical information interoperability between physician clinical systems (EHR) and pharmaceutical clinical trials systems based on open standards. -Duke Medical Center, Duke Clinical Research Institute, CDISC, Novartis, Merck, J&J, Microsoft JAMIA article to be published.

6. 6 Integrating the Healthcare Enterprise IHE is a collaborative initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 (and CDISC!). THE FOUR STEPS OF THE IHE PROCESS I.Identify Interoperability Problems. II.Specify Integration Profiles. III.Test Systems at the Connectathon and Demonstrate at the Interoperability Showcase at HIMSS. IV.Publish Integration Statements for use in RFPs.

7. 7 Integrating the Healthcare Enterprise IHE is a collaborative initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 (and CDISC!). THE FOUR STEPS OF THE IHE PROCESS I.Identify Interoperability Problems. II.Specify Integration Profiles. III.Test Systems at the Connectathon and Demonstrate at the Interoperability Showcase at HIMSS. IV.Publish Integration Statements for use in RFPs. 1. Identify Interoperability Problem

8. 8 Integrating the Healthcare Enterprise IHE is a collaborative initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 (and CDISC!). THE FOUR STEPS OF THE IHE PROCESS I.Identify Interoperability Problems. II.Specify Integration Profiles. III.Test Systems at the Connectathon and Demonstrate at the Interoperability Showcase at HIMSS. IV.Publish Integration Statements for use in RFPs. 2. Specify Integration Profiles Retrieve Form for Data Capture

9. 9 Integrating the Healthcare Enterprise IHE is a collaborative initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 (and CDISC!). THE FOUR STEPS OF THE IHE PROCESS I.Identify Interoperability Problems. II.Specify Integration Profiles. III.Test Systems at the Connectathon and Demonstrate at the Interoperability Showcase at HIMSS. IV.Publish Integration Statements for use in RFPs. 3. Test Systems at the Connectathon and Demonstrate at the HIMSS Interoperability Showcase.

10. 10 Integrating the Healthcare Enterprise IHE is a collaborative initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 (and CDISC!). THE FOUR STEPS OF THE IHE PROCESS I.Identify Interoperability Problems II.Specify Integration Profiles. III.Test Systems at the Connectathon and Demonstrate at the Interoperability Showcase at HIMSS. IV.Publish Integration Statements for use in RFPs. 4. Publish Integration Statements for use in RFPs. Launch three trial implementations: Pfizer/Partners ‘ASTER’ drug safety Lilly/Cerner/Quintiles clinical trial NIH sentinel initiative

11. 11

12. 12 Healthcare Link Technology

13. 13 Medical Research Healthcare Link Healthcare Form Filler Data Archiver Form Manager Data Receiver RFD’s Four Actors enable: Visual integration of eCRF into the EHR Creation of an eSource document independent of the EHR Integration of workflow while maintaining separation of data EHR Protocol

14. 14 ASTER is mentioned twice: p. 7 & p. 20 p. 7, note 12: “CDISC has developed a tool that converts source data from a clinical information system to a format that can be transmitted to regulatory authorities to report clinical trial adverse events. “

15. Current paper-based practice. How RFD mimics the paper flow. Physician/investigator photo-copies a page out of medical record, eyeballs it, edits it, derives needed data for submission, and files it as a paper source document. The chain of custody is severed at that point, and the source is now the paper copy, not the original from the paper chart. Form Filler Form Mgr 3. Form with ‘photocopy’ of EHR data returned to EHR 2. Form Mgr ‘pastes’ the ‘photocopy’ into the form. 4. Investigator eyeballs form, verifies copy, edits, submits data, and saves as eSource, cutting chain of custody. HealthcareResearch 1. Electronic ‘photocopy’ of a medical summary (CCD) routed to Form Mgr

16. 16 Retrieve Form Transaction IHE Grouping Model: Bind content creators and consumers to a single integration profile transaction Content Profile: Clinical Trial Data Integration Profile: RFD Form Manager Content Consumer Standard CRF ODM/CDASH Mapping CCD In CDASH Out Content Creator HL7 CDA Medical Summary (CCD) Form Filler

17. 17 RFD: A Disruptive Innovation “Two paradigmatic trajectories of progress interact.” http://www.12manage.com/methods_christensen_disruptive_innovation.html

18. 18 lbain@cdisc.org Strength through collaboration.