CRIX – A Public Private-Partnership in the US: Structure, Benefits and Lessons Learned Jim Bland Executive Director, CRIX International

What is CRIX? Stands for “Clinical Research Information eXchange” (CRIX). A shared infrastructure for exchange of regulated clinical research information. A community interested in realizing this vision of a shared infrastructure through a public-private partnership. Anticipated delivery of platform and initial services by year end 2007 CRIX International Platform Operator Service Module Developers & Operators Users Service Module X Service Module Y

3 History US Gov’t FDA/NCI IOTF ( ) Industry SEBIX NCI stewardship with broad stakeholder support and participation FIREBIRD pilot Convergence of initiatives caBIG Regulatory Data Exchange Steering Committee (formerly CRIX Steering Committee) December 2006 – CRIX International Association Building upon the visionary work of the Regulatory Data Exchange Steering Committee Has potential for public- private partnership

The Planned CRIX Community Contract Research Organizations Hospital Groups Academic Research Centers Trade and Standards-Setting Organizations Industry Service Providers Patients & Patient Advocates International Community Public Sector Key: = Organizations involved with CRIX = Planned involvement

Value of Information Exchange

Potential Industry Services

An Illustration: Clinical Trial Matching 2. System matches patient to clinical trials (24X7, continuously) Personal Health Records Matching Rules Database Trial Criteria 1. Patient self-reports Personal Health Record 3. Investigator Registry provides contacts to the patient 4. Patient contacts research site: Calls research site Sends Personal Health Record via Secure Message Center. 5. Patient Visits Research Site: Research staff/investigator determine patient eligibility Patient elects whether or not to enroll Authoritative Investigator Registry

CRIX - Current Status & Lessons Learned

CRIX Milestones: 2007 JANFEBMARAPRMAYJUNJULAUGSEPOCTNOVDEC Began Operations Enhancements to the NCI’s FIREBIRD application DEC ‘06 Adverse Events Reporting System CRIX Collaborative Platform Patient Matching FDA RFI Response Operational Partner Selected: NG CRIX Int’l Founded Pfizer Amgen Novartis MySignature Book

CRIX Platform – Year-end 2007 Study Registry CRIX User RegistryCert Registry Single Sign-On User Information & Credentialing CRIX International Portal User Interface Experience Established Repositories & Registries Sponsor Registry Patient Registry Service Provider Registry Content Repository Clinical Data Repository Business Components (Applications) Functionality

Lessons Learned Integration with government regulatory agencies presents challenges –Developing the correct organizational structure to allow regulatory involvement Technical development of the platform will require building interfaces to legacy systems and a gradual migration toward CRIX services In order to address the needs of the European Community, CRIX will need to develop services specifically tailored to EU participants sooner than anticipated Despite some challenges, CRIX is moving ahead faster than anticipated and building momentum in the healthcare community in the US

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