Journal article
Institutional scientific review of cancer clinical research protocols: A unique requirement that affects activation timelines
Journal of Oncology Practice, Vol.13(12), pp.e982-e991
2017
DOI: 10.1200/JOP.2017.024299
PMCID: PMC5728362
PMID: 29019706
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. We sought to evaluate the effect of this process on protocol activation timelines.METHODS: We analyzed oncology clinical trials that underwent full board review by the Harold C. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed 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. The median time from submission to PRMC approval was 55 days. The length of review was associated with trial phase, timing of approval, and number of committee changes/clarifications requested. The median process time was 35 days for those approved at first decision, 68 days for second decision, and 116 days for third decision ( P < .001). The median process time was 39 days if no changes/clarifications were requested, 64 days for one to three changes/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.
Details
- Title: Subtitle
- Institutional scientific review of cancer clinical research protocols: A unique requirement that affects activation timelines
- Creators
- Ning NingJingsheng YanMartin F DietrichXian Jin XieDavid E Gerber
- Resource Type
- Journal article
- Publication Details
- Journal of Oncology Practice, Vol.13(12), pp.e982-e991
- DOI
- 10.1200/JOP.2017.024299
- PMID
- 29019706
- PMCID
- PMC5728362
- NLM abbreviation
- J Oncol Pract
- ISSN
- 1935-469X
- eISSN
- 1935-469X
- Language
- English
- Date published
- 2017
- Academic Unit
- Preventive and Community Dentistry; Biostatistics; Dental Research
- Record Identifier
- 9983917690002771
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