Protocal Review and Monitoring System

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The Protocol Review and Monitoring System [PRMS] of the OSUCCC consists of a Clinical Scientific Review ICommittee [CSRC] and its Executive Committee [EC] that act together to review all cancer-related clinical IProtocols for scientific merit and to monitor scientific progress including accrual rates. Since the last PRMS lapproval in 1999, the CSRC has been reorganized into two teams to facilitate more rapid protocol review and has refined and clarified criteria for scientific progress and prioritization procedures. The CSRC consists of 24 members representing all OSUCCC programs and includes clinical and basic researchers, biostatisticians, pharmacists, a pathologist a research nurse and 2 patient advocates. At bimonthly meetings, the CSRC performs full scientific reviews of all cancer-related clinical protocols initiated by local investigators or pharmaceutical industry sponsors. CSRC approval is required prior to review by the OSU Cancer Institutional Review Board. Formal reviews are required by three members, one of who must be a biostatistician. Reviewers adhere to a review template that includes scientific hypothesis and rationale; experimental design, patient inclusion and exclusion criteria, treatment plan, and statistical considerations to ensure that all review criteria are met. During 2003, 60 new protocols were reviewed resulting in 12 [20%] approved as written, 40 [67%] approved with stipulations, and 8 [13%] deferred or withdrawn. Ongoing studies are monitored for scientific progress every six months. Inadequate accrual is defined as failure to accrue more than 50% of the annual accrual goals over a six-month period. The Executive Committee of seven CSRC members meets monthly to assign reviewers to submitted studies and to assist the CSRC in determining study priorities and in monitoring scientific progress. If there are competing protocols, the EC prioritizes the protocol based on the recommendation of disease specific committees [i.e. Breast, Lung, Hematology, etc.] in collaboration with the study investigator. The CSRC terminates studies that do not show adequate accrual after corrective measures are taken, or fail to meet accepted standards of quality control based on formal audits.