Protocol Review and Monitoring System

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PROJECT SUMMARY The overall mission of the Protocol Review and Monitoring System (PRMS) is to ensure that Stanford Cancer Institute (SCI) investigators execute clinical research that is scientifically meritorious, well designed, distributed across a broad range of cancer disciplines and feasible to conduct. The SCI Scientific Review Committee (SRC) and the disease or modality-oriented Clinical Research Groups (CRGs) together fulfill the PRMS responsibilities for cancer-related clinical research at the SCI and within Stanford. The CRGs conduct the first stage of the selection and prioritization of cancer-related clinical trials, and the SRC conducts the second stage. With the ultimate authority to approve studies, the SRC ensures all cancer-related clinical trials conducted at the SCI are of the highest scientific merit, align with the priorities of the SCI and are feasible to conduct. Over this CCSG cycle, the SRC reviewed an average of 140 new studies each year. The initial SRC study review determination across the grant period was 61% approved, 24% response required, 13% tabled and 2% rejected. An average of 116 studies were reviewed annually for scientific progress. The SRC is responsible for routine scientific progress reviews of studies and has the authority to suspend or close studies due to low accrual, stopping rule violations, changes in scientific relevance or other scientific- based or compliance-based rationales. Major improvements to the PRMS were implemented over this CCSG cycle: · Oversight of PRMS functions was moved under the newly appointed SCI Deputy Director, Heather Wakelee, MD, to enhance separation of PRMS from Clinical Protocol and Data Management which reports to the Associate Director for Clinical Research, Mark Pegram, MD. · A study priority scoring tool was implemented by all CRGs to standardize the first-stage review process, elucidate the impact of proposed studies and facilitate trial prioritization in alignment with the SCI Strategic Plan and catchment area cancer burden and demographics. · A systematic method to calculate accrual progress utilizing an accrual index was implemented for a more effective evaluation of scientific progress, leading to improved action planning. · Annual review of all interventional studies opened to accrual for 5 years or longer for continued scientific relevance. · Enhanced data and safety monitoring plan review was implemented by the SRC to ensure that the management plan was commensurate with the risks of the study