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CRIX – A Public Private-Partnership in the US: Structure, Benefits and Lessons Learned

CRIX – A Public Private-Partnership in the US: Structure, Benefits and Lessons Learned. Jim Bland Executive Director, CRIX International. What is CRIX?. CRIX International. Stands for “Clinical Research Information eXchange” (CRIX).

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CRIX – A Public Private-Partnership in the US: Structure, Benefits and Lessons Learned

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

  2. What is CRIX? CRIX International • Stands for “Clinical Research Information eXchange” (CRIX). • A shared infrastructure for exchange of regulated clinical researchinformation. • 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 Platform Operator Service Module Developers & Operators Service Module X Service Module Y Users

  3. History (2003-2004) Industry SEBIX 2005 - caBIG Regulatory Data Exchange Steering Committee (formerly CRIX Steering Committee) December 2006 – CRIX International Association Convergence of initiatives • Building upon the visionary work of the Regulatory Data Exchange Steering Committee • Has potential for public-private partnership • NCI stewardship with broad stakeholder support and participation • FIREBIRD pilot 2003 - US Gov’t FDA/NCI IOTF

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

  5. Value of Information Exchange

  6. Potential Industry Services

  7. An Illustration: Clinical Trial Matching Database 2. System matches patient to clinical trials (24X7, continuously) Personal Health Records Trial Criteria 1. Patient self-reports Personal Health Record Matching Rules 3. Investigator Registry provides contacts to the patient Authoritative Investigator Registry • 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

  8. CRIX - Current Status & Lessons Learned

  9. CRIX Milestones: 2007 JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC DEC ‘06 CRIXInt’l Founded Began Operations Enhancements to the NCI’s FIREBIRD application FDA RFI Response PfizerAmgen Novartis CRIX Collaborative Platform Adverse Events Reporting System Operational Partner Selected: NG PatientMatching MySignatureBook

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

  11. 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

  12. Q&A

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