Protocol Review and Monitoring System

Ohio State University, Columbus OH

Investigators

Linked publications, trials & patents

Abstract

The Protocol Review and Monitoring System [PRMS] of the OSUCCC consists of a Clinical Scientific Review Committee [CSRC] that reviews all new cancer-related clinical protocols for scientific merit prior to IRB submission and monitors the scientific progress of ongoing studies including accrual rates. The CSRC is organized into two teams to permit a twice monthly meeting schedule and thereby facilitate rapid protocol review. The CSRC consists of 35 members representative of the 6 OSUCCC research programs. Its membership includes clinical and basic researchers, biostatisticians, pharmacists, and research nurses. At its bimonthly meetings, the CSRC performs full scientific reviews of all cancer-related clinical protocols initiated by local investigators or pharmaceutical industry sponsors. CSRC approval of a protocol is required prior to its review by the OSU Cancer Institutional Review Board. Each protocol is reviewed by three CSRC members, one of whom must be a biostatistician, in addition to pharmacy review. Reviewers follow a written review template that calls for an analysis of the scientific hypothesis and rationale, experimental design, patient inclusion and exclusion criteria, treatment plan, and statistical considerations. As of January 2009, all new research protocols undergo review by the CSRC Feasibility Review Committee (FRC), which is a subcommittee of the CSRC. The FRC was implemented to facilitate trial activation and confirm proper prioritization. The FRC does not evaluate the scientific aspects of the protocol, which is left to the CSRC parent committee, but instead evaluates the availability of those resources necessary to implement the protocol. The CSRC Executive Committee (EC) provides oversight to the CSRC. It consists of seven CSRC members that meets monthly to assign new submissions to members for review, to review protocol accrual and ensure that protocol prioritization rules are followed. The CSRC adheres to a set of well-defined criteria for accrual monitoring and trial prioritization. Those ongoing studies that do not show adequate accrual or fail to meet accepted standards of quality control based on formal audits are terminated. In 2009, 8 trials were closed for low accrual: 2 by the PI and 6 by the CSRC. The EC can also perform expedited reviews for appropriate studies (e.g., retrospective reviews). In 2009, 176 new protocols were reviewed by the CSRC with the following results: 32 (18%) were approved as written, 64 (37%) were approved with stipulations, 20 (11%) were deferred, 3 (2%) were withdrawn and 57 (32%) protocols that received outside scientific review were acknowledged. Twenty-eight non-interventional protocols were also approved In an expedited fashion by the CSRC EC.