Protocol Review and Monitoring System

Ohio State University, Columbus OH

Investigators

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Abstract

PROJECT SUMMARY - PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) The Protocol Review and Monitoring System (PRMS) of The Ohio State University Comprehensive Cancer Center (OSUCCC) consists of a Clinical Scientific Review Committee (CSRC) that reviews all new cancer-related clinical protocols for scientific merit prior to Cancer Institutional Review Board (IRB) submission and monitors the scientific progress of ongoing studies including accrual rates. The main CSRC is organized into two teams (with highly similar composition) that collectively meet twice monthly (each once per month), facilitating rapid protocol review. The CSRC consists of 49 members representative of all five OSUCCC research Programs and includes clinical and basic researchers, biostatisticians, and pharmacists. Additionally, ad-hoc members with specific expertise in the areas of cancer prevention and control as well as pediatrics are convened as CSRC sub-committees to provide focused review of these protocols. The CSRC performs full scientific reviews of all cancer-related clinical protocols initiated by local investigators or pharmaceutical industry sponsors, and acknowledges NIH peer-reviewed studies. A quorum (50% of members) and appropriate reviewer expertise must be present to conduct CSRC business. CSRC approval of a protocol is required prior to its review by the OSU Cancer IRB. Each protocol is reviewed by four CSRC members (a primary reviewer, a secondary reviewer, a biostatistician, and a pharmacist). Reviewers follow a written review template including analysis of the scientific hypothesis and rationale, experimental design, patient inclusion and exclusion criteria, treatment plan, statistical plan, data and safety monitoring plan, pharmacy considerations, accrual of underserved populations and patients across the lifespan, and proper prioritization. The CSRC Executive Committee (EC) provides oversight to the CSRC. The EC consists of 11 CSRC members that meet monthly to review protocol accrual and scientific progress and ensure that protocol prioritization rules are followed. The CSRC EC is responsible for communication with investigators whose clinical trials are not meeting accrual goals and for providing support to facilitate accrual. The CSRC adheres to well-defined criteria for accrual monitoring and trial prioritization. Ongoing studies that do not show adequate accrual or fail to meet accepted standards of quality control based on formal audits are terminated. In 2019, the CSRC closed 12 trials for low accrual. The average time from CSRC review to date of approval is 26 days. The EC performs expedited reviews for appropriate studies (e.g., retrospective studies requesting access to medical records). In the last grant period, 1,070 new interventional protocols were reviewed by the CSRC with the following dispositions: 297 (28%) were approved as written, 345 (32%) were approved with stipulations, 76 (7%) were deferred, 297 (28%) were administratively acknowledged after having undergone previous NIH peer-review and 55 (5%) were disapproved. 462 non-interventional protocols were also approved by the CSRC. The CSRC receives protocols that have been reviewed and prioritized by one of the Disease Specific Research Groups that provide a first stage of scientific review.