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

Abstract

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 The remaining studies were disapproved (1), withdrawn (30), given transition phase exceptions (6), or terminated for failure to meet the OEWG deadline (3).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. Pre-OEWG Post-OEWG Phase III trials (Median days) Concept: receipt–approval 86 58 Concept approval–protocol receipt 138 * Protocol receipt–trial activation 497 * Large phase II trials Concept: Receipt–Approval New category post-OEWG, comparison N/A 64 Concept approval–Protocol receipt 76 Protocol receipt–Trial activation * Letters of intent for early phase I and II trials LOI: Receipt–Approval 1131 942 461 572 LOI approval–Protocol receipt 731 532 601 602 Protocol receipt–Trial activation 2851 2842 * * Not yet available.1 Cooperative group data. 2 Non-cooperative group data.