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CTSA IRB Pilot Study Next Steps

CTSA IRB Pilot Study Next Steps. Marc K. Drezner , M.D. Senior Associate Dean School of Medicine and Public Health University of Wisconsin Professor of Medicine. IRB Review. Project Awareness. First Enrollment. Contract.

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CTSA IRB Pilot Study Next Steps

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  1. CTSA IRB Pilot StudyNext Steps Marc K. Drezner, M.D. Senior Associate Dean School of Medicine and Public Health University of Wisconsin Professor of Medicine

  2. IRB Review Project Awareness First Enrollment Contract CTSA Consortium Strategic GoalEnhance National and Translational Research Capability IRB Review Project Awareness First Enrollment Contract

  3. Goal of the CTSA IRB Pilot Study To define relevant metrics based on data analysis that will serve as tools to improve and monitor the management of clinical trial approvals

  4. Validity of the HypothesisUnderlying the Pilot Study Are there definable metrics that when changed can improve the time sequence of IRB approval?

  5. Flow Diagram IRB ApprovalUniversity of Wisconsin Before 2008 Limited IRB Pre-Review IRB Scientific Review Parallel Review

  6. Flow Diagram IRB ApprovalUniversity of Wisconsin 2008-2010 Scientific Review Intensive Pre-Review Research Team ResearchTeam

  7. Effects of Approval at Initial Full IRB Meeting on Duration Now 40% *Timeframe: “After” (7/08-6/09; 12mo); median days

  8. Stages and Duration of IRB Review Process Date of Full IRB meeting Date PI response received Date 1st IRB Pre-Review comments sent to PI Date notice sent to PI Date received by IRB for Pre-Review Date 1st PI response received by IRB Final IRB Approval 12 79 Median Days per Review Stage

  9. Where is the Savings? Date PI response received Date of Full IRB meeting Date 1st IRB Pre-Review comments sent to PI Date notice sent to PI Date received by IRB for Pre-Review Date 1st PI response received by IRB Final IRB Approval 46 Median Days per Review Stage

  10. Duration Results By CTSA The variability in total duration exceeds that consistent with random variation Group 1 (19, 25, 32, 48) - 27-34 d Group 2 (11, 13, 20, 23, 28, 34, 38, 39, 43, 44) - 43-57 d Group 3 (14, 16, 17, 18, 21, 30, 36, 37, 41, 49) - 60-78 d Group 4 (10,22, 24, 26, 33, 40, 45, 46, 47) - 84-146 d The variability evident in durations 1 and 2 further confound analysis as the data from the IRB of institutions in groups 1 and 3 (14, 25) have effectively no duration 2, while the length of durations 1 and 2 do not vary concordantly amongst institutions in the same group (e.g. 23 and 44. These observations provided the initial suggestion that the comparisons made might be inequitable, similar to apples and oranges.

  11. Contributions of the Study Designto the Variability Data from Commerical and Outside IRBs Excluded University of Wisconsin HS IRB Random NCI Central Adult Oncology Studies WIRB Industry-Sponsored Multicenter Deferral PI-Initiated Multicenter Industry-Sponsored Multicenter Multicenter Before 80 After 25

  12. Duration Results by CTSA in Segments

  13. Potential Insights to Duration by CTSA Are the same activities included in the period of time defined as the total IRB duration? Why do some IRBs have no pre-review and the activity flow begins with IRB committee review (16, 18, 19, 28, 32, 39, 46, 47)? When activity flow begins with IRB committee review, what accounts for the short duration of activity during and following review (19, 28, 32) versus the “expected” prolonged activity in others (16, 39, 46, 47)? What accounts for the substantial variability in duration 1 (10, 14, 15, 23, 24, 25, 40, 44 vs 11, 13, 20, 21, 22, 26, 34, 36, 37, 38, 41, 43, 45, 48, 49) and duration 3? Are there inter-relationships between the variability in durations 1 and 3 and the total IRB duration or the percentage of protocols approved at the first full IRB meeting?

  14. Questions Necessary for Clarification of Data • Before and After Protocol Submission • Are any institutionalresources, such as those described below, available to researchers for assistance preparing IRB submissions? • Centralized personnel, such as in an Office of Clinical Trials, who draft and/or revise applications on behalf of research teams • Departmental or other programmatic experts, external to the IRB, who draft and/or revise applications • on behalf of research teams • IRB staff who conduct pre-reviews of application content before formal review by the IRB committee • If available, are these resources utilized prior to or after formal submission of a protocol to the IRB? • For each of the protocols listed in this survey, please identify if such resources were used and if they were used prior to submission of a protocol or after. • Is approval or sign-off from any institutional committee or entity, such as any of the following, required prior to forwarding this application to the IRB for formal consideration or following submission of the protocol but before the protocol can be approved? Can a study be submitted to and approved by an IRB without approval or sign-off from other institutional committees or entities, such as any of the following? • Cancer scientific review committee • Scientific review committee • VA R&D committee • Departmental review committee • Pharmacy review committee • Institutional biological safety committee • Grants and contracts office • FDA (in the case an IND, IDE is needed and has not been granted)

  15. Questions Necessary for Clarification of Data • IRB Activity • Does IRB pre-review include more than 1 interaction with the research team? Are the interactions restricted to written suggestions or do they include personal meetings to make clear suggestions? Is there a limit to the number of revisions permitted prior to submission to the full committee and, if so, how many? • What are the potential actions taken by the IRB committee related to a submission? • Approved without contingencies/modifications • Approved but minor contingencies, modifications, or clarifications must be addressed before final approval can be issued • Deferred or tabled • Disapproved • Other, please explain • Does the response of a research team to the recommendations made by the IRB committee require review by the reconvened IRB committee? • Outside IRBs • During 2009, did your institution use an outside IRB (e.g. commercial IRB) for review of protocols? If so, were the outside IRBs used to review protocols of random type or subject matter or for specific type (e.g. industry-sponsored multi-site study) or subject matter (e.g. pediatric studies)?

  16. Proposal Perform a 3 month study of all active IRBs in the CTSA consortium. Use template derived from the initial study with some modifications and add to the survey new questions that will clarify the data collected. If necessary, conduct short conversations with IRB administrative director to resolve reasons for remaining poorly understood differences of collected data. If analysis of the study is successful, attempt to identify those metrics that facilitate more rapid quality review of submitted protocols. Make public suggestions for metrics that appear to improve IRB function

  17. Effects of Study Type on Duration Industry-Sponsored Multicenter Before 80 After 25

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