Protocol Review and Monitoring System

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PROJECT SUMMARY/ABSTRACT The Protocol Review and Monitoring System (PRMS) provides rigorous scientific review of all human subjects cancer clinical research within the institution, including affiliate sites. The PRMS is responsible for reviewing each research protocol for scientific merit, biostatistical design, accrual estimates, priority within the Sidney Kimmel Comprehensive Cancer Center (SKCCC) disease-/modality-focused Clinical Research Groups (CRGs) and SKCCC, and progress over time. The PRMS accomplishes its charge through a two-stage review process. The first stage includes initial review and prioritization of each trial concept by the CRGs. It is followed by review by a sub-committee of the PRMS Clinical Research Committee (PRMS-CRC), representing Center- wide Shared Resources, to evaluate and provide feedback on feasibility and identify areas of concern to be addressed by the study team before the second stage of review. CRGs are multidisciplinary groups of investigators and research staff, led by designated faculty leaders and assisted by Center-supported CRG Managers. CRGs track studies that are not prioritized to move further and those that move to the second stage. Criteria for review within CRGs include scientific priority, clinical need, protocol leadership, needs of the catchment area and funding source. The second stage of PRMS review includes the scientific and biostatistical review of every cancer-related clinical trial protocol by the PRMS-CRC. The PRMS-CRC receives CRG input on proper prioritization of new and existing protocols. PRMS-CRC Members serve two-year, renewable terms and are appointed by the SKCCC Director. They reflect the scientific Research Programs and CRGs in the Center with representation from biostatistics, pathology, translational labs, patient advocacy and population/ behavioral science. The committee has the authority to approve protocols for Institutional Review Board review that meet the scientific merit and priorities of the SKCCC, and to close protocols that have not demonstrated adequate scientific progress. The PRMS-CRC has a dedicated PRMS Manager. Working with the Clinical Protocol and Data Management Office, initiatives to monitor and improve protocol activation timelines largely reduced the median activation time to 111 days in 2020. There are ongoing efforts to maintain awareness of the importance of inclusion of women, minorities and individuals across the life span in clinical research. These efforts are operational and effective with minority inclusion, consistently aligning with minority representation seen at the SKCCC. Of the 283 studies triaged by CRGs during CY2020, 111 interventional trials were prioritized to move forward. Of the 83 requiring full PRMS-CRC review, 19 were approved as written, 34 were approved with minor clarifications, 23 required re-review for minor modifications and seven for major revisions. Annual scientific reviews were conducted on 134 trials. In 2020, 79 studies closed for various reasons: 66% were completed as planned, 13% were closed for low accrual or competing studies, 12% were closed for issues of feasibility, 5% were closed due to lack of efficacy and 4% were no longer scientifically relevant.