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.
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;105:954-959) 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