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CTSA Improvements in Clinical Research Management

CTSA Improvements in Clinical Research Management . Daniel Rosenblum CTSA Clinical Research Management Coordinator NCRR rosenblumd@mail.NIH.gov Secretary’s Advisory Committee on Human Research Protections October 19, 2010 .

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CTSA Improvements in Clinical Research Management

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  1. CTSA Improvements in Clinical Research Management Daniel Rosenblum CTSA Clinical Research Management Coordinator NCRR rosenblumd@mail.NIH.gov Secretary’s Advisory Committee on Human Research Protections October 19, 2010

  2. Protocol Approval-related Improvements in Clinical Research Management at CTSA Sites • IRB modifications with data to show effect • Reliance Harvard Catalyst (Barbara Bierer) • Common UC Davis (Eric Mah) • Regional Wisconsin (U Wisconsin – Madison) (Nichelle Cobb) • Process stream modification “peri-IRB” • Yale (Tesheia Johnson)

  3. What would constitute Protocol Approval-related “Improvements?” • Reduction in time to study start up? • Better quality? • Increased value, lower cost? CTSA Steering Committee: Time is top priority • Goal: Reduce time significantly, Publish metrics • Current time: 1 – 2 years

  4. Meaningful Improvement Requires • Preservation of processes that assure regulatory compliance • Management of novel interventions, increasing complexity, and undetermined risks • Provision of avenues for local expression of concern for protection of subjects (“it’s not just the protocol”) • Development of published metrics that document speedier start up, improved quality, and reasonable cost • Pursuit of the mission of developing an improved academic home for clinical research

  5. In Search of Process “Improvements” • Will improved “IRB” management speed study start up? • IRB review time at CTSA sites • Data on IRB review still being analyzed, second protocol • Alternative models (Harvard, UC Davis, Wisconsin) • Data on usage • Discussion of details • Evidence of reduction in time to study start up • Will improvement in other factors speed study start up? • Process mapping/streamlining example (Yale) • Issues in process streamlining • IRB authority – HRP plus scientific, budget, finance, other • Process streams, tracking • Governance: Authority, responsibility, control

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