Purpose The National Cancer Institute (NCI) requirement that clinical trials at NCI-designated cancer centers undergo institutional scientific review in addition to institutional review board evaluation is unique among medical specialties. Wesought to evaluate the effect of this process on protocol activation timelines. Methods Weanalyzed oncology clinical trials that underwent full board review by theHaroldC. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013.Weanalyzed associations between trial characteristics, PRMC decisions, protocol modifications, and process timelines using the χ2 test, Fisher's exact test, Wilcoxon rank sum test, Kruskal-Wallis test, and logistic regression. Results A total of 226 trials were analyzed. Of these, 77% were industry sponsored and 23% were investigator initiated.Themedian timefromsubmissiontoPRMCapprovalwas55days.Thelength of review was associated with trial phase, timing of approval, and number of committee changes/ clarifications requested. Themedian process timewas 35 days for those approved at first decision, 68daysforseconddecision, and116daysforthirddecision(P, .001).Themedianprocesstimewas 39daysifnochanges/clarificationswererequested, 64days foroneto threechanges/clarifications, and 73 days for four or more changes/clarifications (P<.001). Requested changes/clarifications had a greater effect on industry-sponsored trials than on investigator-initiated trials. Conclusion NCI-mandated institutional scientific review of oncology clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.
ASJC Scopus subject areas
- Health Policy