Reforms speed initiation of NCI-sponsored clinical trials
The process of opening a cancer clinical trial for patient accrual often takes years, which can significantly slow the testing of potentially valuable therapies. Research has shown that trials which are slow to register patients often fail to finish. Following a thorough review of this sequence of events—from idea submission to trial initiation—NCI’s Operational Efficiency Working Group (OEWG), produced a series of recommendations that are now being implemented, including:
- the ideal, or target, time to open a clinical trial should be 210 days for phase I and phase II trials; and 300 days for phase III trials
- absolute deadlines—which, when surpassed, lead to cancellation of the trial— should be set at 540 days for phase I and II trials; and 720 days for phase III trials.
A new study, examining the outcomes of the OWEG recommendations, was led by Jeffrey Abrams, M.D., NCI acting director for clinical research, in collaboration with a team of clinical trial experts from NCI and its Cooperative Groups. Their study showed that the OEWG recommendations resulted in a median 18.3 percent reduction (from 541 to 442 days) in the time it takes to initiate phase I and phase II trials. The decrease seen in phase III trials was even more encouraging, with a median reduction time of 45.7 percent (from 727 days to 395 days). Although these median times don’t yet match the ideal OEWG target deadlines, they fall well within the absolute deadline recommendations. Because of the success in exceeding absolute deadlines, NCI shortened the timeframe even further for studies received for review after April 5, 2012, with an absolute deadline of 450 days for early phase trials and 540 days for phase III trials. This study of OWEG outcomes appeared online in the Journal of the National Cancer Institute, June 17, 2013.