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The Cancer Therapy Evaluation Program's (CTEP) implementation of the Operational Efficiency Working Group (OEWG) recommendations.

6113 Background: In March 2010, the OEWG recommended strategies to decrease the activation time for NCI-sponsored clinical trials. A major element of the recommendations was the establishment of target timelines (210 days for phase I and II, 300 days for phase III) and absolute deadlines (540 days for phase I and II, 730 days for phase III) for studies to go from study submission to trial activation (i.e., open for patient enrollment). In response to the OEWG recommendations CTEP established new policies and procedures to streamline the protocol development process.


METHODS
CTEP hired Project Managers to track studies from submission through activation, developed a secure website to allow investigators real-time milestone monitoring, and instituted routine conference calls between CTEP reviewers and investigators at key timeline points to quickly resolve issues and decrease revisions. Also, CTEP's enforcement of the absolute deadlines began on 1/1/11.


RESULTS
Since 4/1/10, 161 studies have been submitted and 196 conference calls have occurred. Of 122 studies with an absolute deadline of 1/1/11, 67% were activated before the deadline. The remaining studies were disapproved (1), withdrawn (30), given transition phase exceptions (6), or terminated for failure to meet the OEWG deadline (3). Preliminary data below shows an overall decrease in timelines.


CONCLUSIONS
There is early evidence of timeline reduction since implementation of the OEWG recommendations. Updated results will be presented on timelines for all stages of protocol development and trial activation, including number of revisions required. [Table: see text].