1. Healthcare Link Initiatives: Bridging Clinical Research and Healthcare
Clinical Observations Interoperability
Telcon
28 August 2007
Landen Bain
CDISC Liaison to Healthcare

2. Mission Statement
The mission of CDISC is to develop and support global,
platform-independent data standards that enable information system interoperability
to improve medical research and related areas of healthcare.

3. Clinical Data Interchange Standards Consortium (CDISC)
Global, open, multidisciplinary, non-profit organization initiated in 1997 as a volunteer group
Incorporated in 2000; now > 170 member corporations
Including academic research centers, global biopharmaceutical companies, technology and service providers, IRBs….
Active Coordinating Committees in Europe and Japan
Plus 7 User Networks spanning the U.S.
One of Becky’s slides from _ISOSummit_Montreal_rdk.ppt.

4. 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
Identify Interoperability Problems.
Specify Integration Profiles.
Test Systems at the Connectathon and Demonstrate at the Interoperability Showcase at HIMSS.
Publish Integration Statements for use in RFPs.

5. Our Use Case 1 6 5 2 3 4
EDC without data standards, courtesy Charles Jaffe, MD, PhD

6. 2/3 of sites have more than one data capture system. 17% have 5 or more!
My simplifies version.

7. Retrieve Form for Data-capture
Retrieve Form for Data Capture (RFD), is an IHE integration profile which enables data capture for clinical research, drug safety, and other purposes within an EHR session.
By collecting two types of data at a single source - the point of care EHR system--physicians and staff need not re-enter data into specialized research and surveillance applications.
Avoiding redundant data entry reduces data errors and saves the care provider’s valuable time while allowing key data to be reported in a timely and accurate manner.

8. Problem Focus Retrieve form is problem focused:
Address the multiple data entry systems at sites.
Retrieve form is experimental :
Introduce the technique into a site and observe what happens.
Retrieve form is developmental:
Start simple and iterate improvements.

9. Start with the Obvious Problem

10. Clinical Site Secondary Uses Primary Use EHR Clinical Trial Sponsor
Disease Registry
Clinical Trial
Sponsor
Entry Form
Case Report Form
Public Health Org.
Outbreak Report
Safety Org.
Adverse Event
Data
Secondary Uses
Site staff must engage with multiple systems.
Primary and secondary uses do not align.
The site staff engage with just one system: the EHR
The EHR takes over as the pivotal data broker
Primary and secondary uses of data align
Primary Use
EHR

11. Retrieve Form for Data-capture
RFD uses the XForms standard to present data capture forms from external agencies to an EHR.

12. Clinical Trial: Lab & Image Data Clinical Trial: Visit Workflow
Drug Safety
Sponsored by
Clinical Trial: Lab & Image Data
Sponsored by
Clinical Trial: Visit Workflow
Sponsored by
Disease Registry
Sponsored by
Bio-Surveillance
Sponsored by

13. RFD Trial Implementation Version
IHE Information Infrastructure Technical committee, July Includes capabilities for data clarification and security.
Formal Connectathon 2008
Content work in Patient Care Coordination Technical Committee will
Bind RFD to CDA, ODM, ICSR, CDASH, …
CDISC’s Terminology project will define code lists for standard data elements.

14. Next Steps: Real World Implementations
Pfizer: drug safety with Partners - underway
Eli Lilly: observational trial with Cerner & Quintiles - committed
NIH – Safety Reporting - committed
Novartis: Images – likely
Others
MD Anderson
J&J, Medidata, GE, SAS
AP-HP
Boston Scientific
Genzyme
Parexel
CareSpark

15. Parallel Activities
EHR Vendors’ Association, 30 vendors, organized by HIMSS.
HIT Forum, Suzanne Markel-Fox, GSK and Steve Labkoff, Pfizer.
HIMSS Life Sciences Group, Jeff David.
IMPACC, CIOs’ group within PhRMA. (Will take leadership of HIT Forum.)
EDC task force of bio-stat group (BDM) of PhRMA, Catherine Celignant. White paper on CDISC web site.
June 13th group: Charlie Saffron of Harvard.
AMIA's Secondary Data Use Group and Clinical Trial workgroup, Charlie Barr.
eHealth Initiative, Janet Marchibroda.
Semantic web life science group of WWW Consortium, Eric Neumann.
EFPIA group in Europe, Isabelle de Zegher, Novartis.
Accenture Slipstream project, John Apathy.
eClinical Forum.
MIT Center for BioMedical Innovation, EHR committee, Hugh Donovan
HL7 RCRIM
Open Group UDEF Health Care Project, Thomas Brunner, Novartis
SAFE
CRIX
OASIS
FDA ePlatform
FDA Sentinel System

16. ONLY CONNECT
EHR
CDISC