TY - JOUR
T1 - Institutional scientific review of cancer clinical research protocols
T2 - A unique requirement that affects activation timelines
AU - Ning, Ning
AU - Yan, Jingsheng
AU - Dietrich, Martin F.
AU - Xie, Xian Jin
AU - Gerber, David E.
N1 - Funding Information:
Supported by a National Institutes of Health Midcareer Investigator Award in Patient-Oriented Research (K24CA201543-01; to D.E.G.), a National Cancer Institute Clinical Investigator Team Leadership Award (1P30 CA142543-01 supplement; to D.E.G.), a National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases Short-Term Institutional Research Training Grant (5 T35 DK 66141-10; to N.N.), and the National Center for Advancing Translational Sciences University of Texas Southwestern Center for Translational Medicine (U54 RFA-TR-12-006). Biostatistical support provided by the Biostatistics Shared Resource at the Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX, which is supported in part by a National Cancer Institute Cancer Center Support Grant (1P30 CA142543-01). Presented in abstract form at the American Society of Clinical Oncology Annual Meeting, Chicago, IL, June 2-7, 2017. We thank Helen Mayo, MLS, University of Texas Southwestern Medical Library, for assistance with literature searches and Dru Gray for assistance with manuscript preparation.
Publisher Copyright:
Copyright © 2018 American Society of Clinical Oncology. All rights reserved.
PY - 2017/12
Y1 - 2017/12
N2 - 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.
AB - 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.
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U2 - 10.1200/JOP.2017.024299
DO - 10.1200/JOP.2017.024299
M3 - Review article
C2 - 29019706
AN - SCOPUS:85039944654
SN - 1554-7477
VL - 13
SP - e982-e991
JO - Journal of oncology practice
JF - Journal of oncology practice
IS - 12
ER -