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

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.

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 2007-03_ISOSummit_Montreal_rdk.ppt.

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.

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

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

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.

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.

Start with the Obvious Problem

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

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

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

RFD Trial Implementation Version Approved @ IHE Information Infrastructure Technical committee, July 2007. Includes capabilities for data clarification and security. Formal testing @ 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.

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

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

ONLY CONNECT EHR CDISC lbain@cdisc.org