CDISC Strategy Joint Initiative Council 18 October 2011

CDISC Strategy Joint Initiative Council 18 October 2011 Bron Kisler, VP, Strategic Initiatives, Current JIC Leader Rebecca D. Kush, Ph. D, President and CEO, CDISC © CDISC 2011 1

World Standards Day International standards Creating CONFIDENCE Globally 14 October 2011 © CDISC 2011 2

CDISC Vision: Informing patient care and safety through higher quality medical research © CDISC 2011

CDISC Strategic Goals 2012 ~ 2015 # 1 Core Standards for Aggregate Data Analysis • Achieve significant progress in the use of core CDISC standards to allow scientifically sound data aggregation and support secondary uses of research data for the purposes of scientific investigation and comparative effectiveness. Examples: • FDA and NCI are developing a Clinical Trial Repository (CTR); the model will be open. It is based on BRIDG and SDTM. • Critical Path Institute is developing open, shared databases through Coalition Against Major Diseases (CAMD); based on SDTM, developing CDASH. © CDISC 2011 4

Public Release of Alzheimer's Clinical Trial Data By Pharmaceutical Researchers PR Newswire WASHINGTON, 11 June 2010 First Combined Pharmaceutical Trial Data on Neuro-degenerative Diseases; Shared Resource from Unique Public-Private Partnership Will Help Accelerate Alzheimer's, Parkinson's, and Other Brain Disease Research WASHINGTON, June 11 /PRNewswire-USNewswire/ -- A new database of more than 4, 000 Alzheimer's disease patients who have participated in 11 industry-sponsored clinical trials will be released today by the Coalition Against Major Diseases (CAMD). This is the first database of combined clinical trials to be openly shared by pharmaceutical companies and made available to qualified researchers around the world. Initial database required mapping to a standard (CDISC); can now be leveraged to collect data using the standard. © CDISC 2011 5

CDISC Strategic Goals 2012 ~ 2015 # 2 Healthcare/Research Data Interoperability • Achieve significant progress in enabling interoperability between clinical care and clinical research, and explore expansion from bench to bedside • By linking these realms through standards, CDISC will follow its principle of collecting data once, using it many times, so that research informs healthcare, and healthcare informs research. Examples: • CDISC-IHE Integration Profiles, e. g. RFD • EHR for Clinical Research Functional Profile • IMI EHR 4 CR and Interoperability Showcases © CDISC 2011 6

CDISC Strategic Goals 2012 ~ 2015 # 3 Semantics • Develop CDISC SHARE, a global, accessible, electronic library for CDISC content. • CDISC SHARE will enable precise and standardized data element definitions and richer metadata that can be reused within applications and across studies to improve biomedical research and its link with healthcare. Examples: • SHARE = Shared Health and Research Electronic Library; stakeholder survey of > 70 participants agreed on value. • Concepts for research developed; infrastructure ‘on hold’ due to NCI evaluation…seeking global solution. © CDISC 2011 7

CDISC Strategic Goals 2012 ~ 2015 • # 4 Therapeutic/Specialty Area Standards • Expedite the development and rollout of new therapeutic-area or specialty standards while continuing to refine, support and educate on existing standards. • Incorporating therapeutic area needs into existing CDISC standards will ensure consistency in data capture and analysis for therapeutic endpoints and other disease-specific data elements to address efficacy and other aspects of trials. Examples: Alzheimer’s disease…. . © CDISC 2011 8

Now published…. CDISC Alzheimer’s Disease SDTM User Guide (Version 1. 0) © © CDISC 2011 See also “Questionnaires” on the CDISC website under Standards & Innovations. 9

CDISC Strategic Goals 2012 ~ 2015 # 5 Ensure CDISC Infrastructure to Support the first four goals! § § § Standards Maintenance Legal/HR/Accounting Education Alliances Member Relations Public Relations § Communications © CDISC 2011 10

Recent Lessons from the HIT Standards Committee Chairs • We need to balance innovation vs. specification; don’t ‘constrain’ but rather define what can be supported. • Learn from others who have pushed the envelope. • In many countries, developers cannot articulate a standard until it is perfect; since it is never perfect, it is never articulated. • One way of thinking of a definition for standards is that they are ‘implementable’ and that their success is measured by adoption vs. volumes of documentation: “Standards aren’t created; they are adopted. ” Quotes from HITSC Chairs, Jonathan Perlin and John Halamka CDISC Blog and e. News 7 October 2011 © CDISC 2011 11

CDISC Operational Direction a) managing a robust, quality process that is far more streamlined than the one we used for developing our core standards; b) thinking outside of the box in order to develop such a process and accompanying tools such as SHARE; c) linking our work with healthcare and genomics standards; d) re-engaging our CDISC volunteers and engaging new volunteers from around the globe; e) not expecting a perfectly complete standard before it is made available for comment, testing, iteration, improvement and gradually broader adoption; f) build upon our core standards; g) increase adoption. © CDISC 2011 12