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An ARRA Supported Administrative Supplement to the University of Washington

Analysis of Clinical Research Management of Multi-Site Clinical Studies and Trials in Cystic Fibrosis at CTSAs over a 3.5year Period. An ARRA Supported Administrative Supplement to the University of Washington. Aims of the Project. Identify sites to benchmark from review of metrics data

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An ARRA Supported Administrative Supplement to the University of Washington

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  1. Analysis of Clinical Research Management of Multi-Site Clinical Studies and Trials in Cystic Fibrosis at CTSAs over a 3.5year Period An ARRA Supported Administrative Supplement to the University of Washington

  2. Aims of the Project • Identify sites to benchmark from review of metrics data • Conduct the benchmarking activities • Summarize best practices and develop an Action Guide for Improving Clinical Research Processes

  3. Collecting the Metrics Data • 77 TDN centers (31 CTSA) • Size range (55 to 750 CF patients) • 3.5 years of solid metrics data • 189 interventional and observational (single and multi-center) studies that are ongoing or complete • 58 multi-center interventional or outcome measure development studies with completed enrollment (Primary metrics data analysis set) • CCSM

  4. The CCSM Data Entry Screen

  5. Analyzing the Metrics Data • Key metrics • Starting studies (IRB, Contract, enrollment of first patient) • Finishing studies (enrollment of patients into studies) IRB Contract Approval to Enroll First Patient Enrolled

  6. Challenges with Metrics • All studies are not created equal • All CF centers are not created equal • Have to normalize the data in some way to make it comparable • Current analyses normalize in a simple way • Quartile performance for timing metrics • Consider denominator (site size) for enrollment metrics • Study weighting factor • Want to confirm that the simple way provides adequate normalization

  7. Composite Analysis

  8. Benchmarking Protocol • Two day site visit: • Observation of facilities/research team processes (recruitment, study visits, administrative) • Site presentation of their overall process • Qualitative interviews with (match interviewer expertise with interviewee): • Investigators • Research Coordinators • Clinical team • Institutional leadership • IRB administrator (may be done by telephone)* • Contracts/budget administrator (may be done by telephone)*

  9. Timeline • Protocol IRB approved (April) • First benchmarking visit complete (July) • Conclude benchmarking visits (Dec) • Complete analysis (end Q1 2011) • Present at 2011 CTSA Workshop (June, 2011) • Action Guide (end of Q3 2011) • Publish results (submit by end of Q4, 2011)

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