Changes made 5 years ago to accelerate time-to-initiation of clinical trials sponsored by the National Cancer Institute (NCI) in Bethesda, Maryland, have paid off in the form of faster activation of studies, according to a recent review of the revised processes.
In 2008, the NCI established the Operational Efficiency Working Group (OEWG) to help expedite NCI-sponsored clinical trials from the idea stage to patient enrollment. Changes included the addition of new NCI staff positions to monitor progress, protocol-tracking Web sites, and strategically planned conference calls.
One of the most significant measures was the implementation of absolute deadlines: The target timelines for phase I-II and phase III studies were set at 7 months and 10 months, respectively, but absolute deadlines of 18 months and 24 months, respectively, were established as well. Any trial not activated by the absolute deadline is automatically disapproved.
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Jeffrey Abrams, MD, of the NCI’s Division of Cancer Treatment and Diagnosis, and colleagues compared trial-initiation times before and after the OEWG’s overhaul. They found that for 525 pre- OEWG and 152 post-OEWG phase I-II trials, median time to activation decreased by 18.3%, from 541 days to 442 days. The median time to activation was cut nearly in half, falling by 45.7% from 727 days (for 112 pre-OEWG trials) to 395 days (for 24 post- OEWG trials). No trial reached or exceeded the absolute deadline.
Abrams and coauthors reported in Journal of the National Cancer Institute (2013;105[13]:954-959) that based on this progress, the absolute deadlines will now be reduced further, to 15 months for phase I-II trials and 18 months for phase III trials. This will likely shorten the wait for trial results to reach oncology patients who are in need of new treatments. ONA
