Protocol Review and Monitoring System

$114,720P30FY2016CANIH

Research Inst Of Fox Chase Can Ctr, Philadelphia PA

Investigators

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Abstract

PROJECT SUMMARY/ABSTRACT ? PROTOCOL REVIEW AND MONITORING SYSTEM The PRMS at Fox Chase Cancer Center (FCCC) is spearheaded by the Research Review Committee (RRC). The RRC evaluates and provides scientific prioritization of all therapeutic trials at FCCC, with particular emphasis on investigator initiated studies. The RRC is comprised of physicians from all oncologic disciplines, translational researchers, pharmacists, biostatisticians, as well as researchers from nursing and the Cancer Prevention and Control Program. In addition all new protocols that contain human research at FCCC are reviewed. Prior to scientific review, Disease Site Teams, with input from Translational Research Disease Groups, determine the clinical priority of interventional studies, based on their clinical research agenda and the existence of competing trials. Once submitted for review, the Clinical Trials Office (CTO) feasibility committee evaluates protocols to determine if sufficient resources will or will not be available from the CTO. With the affiliation with Temple University Health System, studies arising on the Temple University Health Science Center campus are subject to the same review process. The goals of the review are to ensure that the study being evaluated has: 1. A clear hypothesis 2. A relevant biologic or therapeutic question 3. Appropriate scientific design to answer the question being asked 4. Appropriate resources for the conduct of the study 5. Appropriate statistical design to answer the question being asked 6. Appropriate data and safety oversight, if applicable 7. Scientific prioritization for therapeutic trials supported by CTO resources The RRC is also responsible for monitoring accrual at the time of the annual continuing reviews, to ensure that the use of ongoing CTO resources in support of studies is justified. To assist with this function, the Protocol Accrual Subcommittee (PAC) of the RRC has been formed. The subcommittee meets bi-weekly to review accruals and communicate with investigators whose protocols are at risk for termination due to poor accrual.

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