Creation of a national volunteer for research web portal National Advisory Research Resources Council February 12, 2009

1. Creation of a national volunteer for research web portalNational Advisory Research Resources CouncilFebruary 12, 2009 Paul Harris, PhD Director, CTSA Informatics Operations Department of Biomedical Informatics Vanderbilt University

2. Agenda Recruitment Needs Assessment Vanderbilt Local Registry (Case Study) National Registry Model CTSA Participation Model and Regulatory Oversight Progress Report

3. Recruitment Needs Assessment

4. Participant Recruitment ? Barrier to the Efficiency of Clinical and Translational Research Difficult to efficiently identify and enroll participants, which… frustrates investigators can result in statistically underpowered studies slows the pace of translation CTSA RFA lists ‘recruitment strategies’ as an important common issue

5. National Recruitment Registry Maps to CTSA PI-Defined National Strategic Priorities Enhancing national clinical and translational research capability Enhanced and standardized clinical research management Improved research infrastructure phenotyping - human and preclinical models Enhancing the training and career development of clinical and translational scientists Enhancing consortium-wide collaborations social networking inventory of resources data sharing Enhancing the health of our communities and the nation community engagement public health policy

6. Benefits: National Recruitment Registry Researchers Provides a database of people already interested in participating Registry + ? Study Exposure ? ? Enrollment and ?Study Duration Potential Participants Self-guided exposure to research Practical help in finding research opportunities across institutions CTSA Institutions (later any institution) Cost-effective resource for local researchers Opportunities & tools for studying recruitment methods (research on research) Society Speeds approval of effective therapies Every taxpayer can participate (regardless of geographical location)

7. Vanderbilt Local Registry (Case Study)

8. Consumer Site: Clinical Studies

9. Consumer Site: Clinical Studies

11. Recruitment Registry - Researcher Site

14. Recruitment Registry Utilization

15. Consumer Site Traffic

16. Local Registry – Lessons Learned

17. National Registry Model

19. Consumer Site – Framework Institution-neutral domain name Co-locate registry with listings of registered studies known to be recruiting Leverage ClinicalTrials.gov data to automatically suggest potential studies outside CTSA domain

20. CTSA Participation Model and Regulatory Oversight

21. CTSA Participation Model Each participating CTSA will appoint a liaison Liaison responsibilities: Local IRB awareness/agreement of program and methods/protections Electronic promotional announcements to populate registry in local area Gatekeeper and point of contact for local researchers PI communications to build utilization

22. Regulatory Oversight Vanderbilt IRB responsible for all human subject protections for the national registry Vanderbilt IRB will make ‘packet information’ available to each site’s liaison Meeting minutes Metrics Usage Continuing review information Complaints

23. Progress Report

24. Target Timeline

25. CTSA Stakeholder MeetingVanderbilt University, Dec 16, 2008

26. Questions?