Institutional scientific review of cancer clinical research protocols

A unique requirement that affects activation timelines

Ning Ning, Jingsheng Yan, Martin F. Dietrich, Xian Jin Xie, David E. Gerber

Research output: Contribution to journalReview article

Abstract

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.

Original languageEnglish (US)
Pages (from-to)e982-e991
JournalJournal of Oncology Practice
Volume13
Issue number12
DOIs
StatePublished - Dec 1 2017

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National Cancer Institute (U.S.)
Clinical Protocols
Clinical Trials
Advisory Committees
Nonparametric Statistics
Industry
Research Personnel
Neoplasms
Research Ethics Committees
Logistic Models
Medicine
Research
TimeLine

ASJC Scopus subject areas

  • Oncology
  • Oncology(nursing)
  • Health Policy

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Institutional scientific review of cancer clinical research protocols : A unique requirement that affects activation timelines. / Ning, Ning; Yan, Jingsheng; Dietrich, Martin F.; Xie, Xian Jin; Gerber, David E.

In: Journal of Oncology Practice, Vol. 13, No. 12, 01.12.2017, p. e982-e991.

Research output: Contribution to journalReview article

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abstract = "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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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.

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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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