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Vol. LXI, No. 15
July 24, 2009

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CTSA Consortium Drafts Clinical Research Management Improvement Plan

Leaders of the Clinical and Translational Science Award (CTSA) consortium announced a plan to improve clinical research management (CRM) at CTSA sites nationwide. The plan recommends 1) using data-driven methods of process improvement, 2) motivating “champions of change” at each site to drive improvement, 3) publishing comparable data on each site to foster awareness of the need for improvement, 4) sharing best practices as teaching tools, 5) adopting standards in CRM across the CTSA consortium and 6) monitoring results and intervening as needed.

Industry, stakeholder groups, private consulting firms, NIH and CTSA sites are eager to improve CRM at U.S. academic medical centers (AMCs) because many have slow, inefficient and unreliable clinical trial performance characteristics. CRM at many S. AMCs includes unnecessary process steps and lengthy delays, insufficient enrollment, high rates of non-compliance and insufficient trial completion. For example, at many sites, it can take many months to activate an investigator-initiated protocol or to sign a contract and more than a year to enroll the first patient. Trials conducted outside the U.S. often are completed more quickly at locations where processes are months shorter and far less costly.

The CRM improvement plan grew out of discussions at the second annual Clinical Research Management Workshop, held June 22-23 at the Natcher Conference Center. The National Center for Research Resources, in conjunction with the CTSA consortium and the Yale Center for Clinical Investigation, sponsored the event.

To view presentations from the workshop, visit

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