PROTOCOL REVIEW AND MONITORING SYSTEMThe Protocol Review and Monitoring Committee (PRMC) of the Kimmel Cancer Center (KCC) is an integralcomponent of the KCC clinical investigations activities. The KCC PRMC reviews all new researchproposals involving human subjects and neoplastic diseases. Proposals receive a pre-review by thepertinent disease-specific working group, which provides a written evaluation of protocol feasibility, lack ofcompetitive protocols or stratification if overlap with other protocols exists, and compatibility with KCCresearch and accrual goals. The Clinical Research Management Office (CRMO) staff prepares thedocumentation and coordinates meetings and communications for the PRMC.
The specific aims of thePRMC are to (1). Maintain a review committee of KCC investigators, with representation from basic scienceand clinical areas, responsible for the initial scientific review and monitoring of all ongoing clinical trials, (2)Evaluate the scientific merit of new proposals, (3) Establish criteria for prioritizing competing KCC studies,(4) Monitor accrual to clinical studies and terminate those studies that fail to meet objectives based onprotocol specifications in a timely manner, (5) Maintain a collaborative relationship with the UniversityInstitutional Review Board and the KCC Data and Safety Monitoring Board (DSMB) to facilitate interactionbetween the three review committees, (6) Assure protocol compliance through the review of data auditsconducted by the CRMO. The PRMC initial scientific review of each proposed study focuses on: (1) studyvalue; (2) methods; (3) investigator(s) experience and (4) patient resources. The PRMC considers one offive actions for each study: (1) approved as written, no changes required; (2) approved with advisorychanges only, no further committee action required; (3) approved in concept with changes or justificationrequested; (4) tabled for additional investigator input/clarification or (5) rejected. The PRMC holds regularmeetings twice per month during which each protocol involving human subjects submitted to be opened atKCC is discussed and evaluated. Investigator-initiated and industry-sponsored protocols undergo rigorousfull scientific peer review, including biostatisties, as well as pharmacy, nursing, financial and workloadreview. All National Cancer Institute cooperative group protocols are eligibl e to undergo expedited review toprioritize for implementation. In the period 1/1/06-12/31/06, 59 protocols were submitted for PRMC review.Of these, 26 were cooperative group; of the remaining 33 protocols, 6 were externally peer reviewedprotocols, 14 were investigator initiated protocols and 13 were industrial protocols. In the period 1/1/06-2/31/06 36 protocols were approved and activated, 14 were deferred for revision, 16 were approved but notactivated in this time frame, and 7 were ultimately disapproved.
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