In recent years, the process of cancer clinical trial activation has come under scrutiny. Study activation barriers and delays limit treatment options available to patients, increase research costs, hinder trial accrual, and may result in study objectives becoming obsolete.1 Researchers have voiced concerns about the complexity, length, inconsistencies, excessive demands, and inappropriate conservatism of the review process.2–6 In turn, these steps contribute to delays in and escalating costs of developing new therapies.7–9 As a result, efforts are underway to streamline and accelerate these processes.10,11 Studies of the clinical trial activation process have focused on the individual contributions of the process components (eg, ethical review, budget, contract, site visit, supply shipment) and comparisons among institutions.12–14
As part of this process, the NCI mandates that any clinical trials involving patients with cancer at NCI-designated cancer centers undergo institutional formal scientific review. Studies covered by this requirement include interventional clinical trials, noninterventional studies, tissue banks, and medical records review. This process occurs in addition to ethical review by an Institutional Review Board (IRB). This separate scientific review requirement seems to be unique among medical fields; clinical trials that do not involve patients with cancer generally require only IRB review. Furthermore, clinical cancer research conducted at non–NCI-designated centers in the United States or at cancer centers in other countries may not be subject to this requirement.
Although the role of IRBs in clinical research conduct has been described extensively,4,15–17 there is a dearth of information on the effect of scientific review committees on protocol design and content. We therefore reviewed the decisions, requested changes and clarifications, and resulting protocol modifications of the Protocol Review and Monitoring Committee (PRMC) made at the Harold C. Simmons Cancer Center at the University of Texas (UT) Southwestern Medical Center within a recent 5-year period.
The authors have disclosed that they have no financial interests, arrangements, affiliations, or commercial interests with the manufacturers of any products discussed in this article or their competitors.
This work was supported by a National Cancer Institute Cancer Clinical Investigator Team Leadership Award (1P30 CA142543-01 supplement) (to D.E.G.) and by 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.). Biostatistical support was provided by the Biostatistics Shared Resource at the Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, which is supported in part by National Cancer Institute Cancer Center Support Grant, 1P30 CA142543-01.
The data presented in this article were presented in an abstract at the 2014 ASCO Annual Meeting; May 31–June 3, 2014; Chicago, IL.
The authors wish to thank Tiffany Levine, Arlene Thomas, Jennifer Davis, and Erin Williams from the Simmons Cancer Center Clinical Research Office for assistance collecting Protocol Review and Monitoring Committee documents. The authors would also like to thank Helen Mayo, MLS, from the UT Southwestern Medical Library for assistance performing literature searches.
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