2021 |
Courtney, Kevin D |
P30Activity Code Description: To support shared resources and facilities for categorical research by a number of investigators from different disciplines who provide a multidisciplinary approach to a joint research effort or from the same discipline who focus on a common research problem. The core grant is integrated with the center's component projects or program projects, though funded independently from them. This support, by providing more accessible resources, is expected to assure a greater productivity than from the separate projects and program projects. |
Protocol Review and Monitoring System @ Ut Southwestern Medical Center
The Simmons Comprehensive Cancer Center (SCCC) Protocol Review and Monitoring System (PRMS) provides independent peer review for scientific merit, prioritization, and monitoring for all cancer-related clinical and population science studies conducted at the UT Southwestern Medical Center (UTSW) and its affiliated healthcare systems, Parkland Health and Hospital System and Children?s Medical Center. PRMS functions are accomplished by a rigorous review in a two-stage process conducted by: 1) SCCC Disease-Oriented Teams (DOTs), where initial assessment of value, fit, and prioritization within the existing portfolio of studies is performed, as well as an assessment of each study?s operational and accrual feasibility; and 2) the Protocol Review and Monitoring Committee (PRMC), which is the definitive independent authority for determining which studies proceed to activation. The PRMC ensures that all SCCC-aligned cancer research studies involving human subjects are (1) scientifically sound, (2) effectively designed, (3) appropriately prioritized within DOT research portfolios, (4) aligned with SCCC institutional clinical research priorities, (5) feasible for completion, (6) inclusive of appropriate data and safety monitoring plans, and (7) monitored regularly for accrual and scientific progress. Utilizing standard operating policies and procedures, the PRMS is conducted by 13 DOTs and three PRMCs (two for clinical studies and one for population studies), under the leadership of Hans Hammers, MD, PhD (PRMC1), Robert Timmerman, MD (PRMC2), and Simon Craddock Lee, PhD, MPH (Population Science PRMC). During the current project period, the PRMS made substantial progress in key areas, including implementing parallel review with the Institutional Review Board (IRB) while still requiring PRMC approval before IRB approval, increasing PRMC meeting frequency, expanding PRMC membership, and transitioning to a fully electronic review process, all of which have contributed to decreased review timelines while maintaining the highest scientific standards. In 2019, the SCCC DOTs vetted 197 studies for potential submission and forwarded 162 studies for PRMC review. Of these, 50 had undergone an appropriate external scientific peer review and therefore received an expedited review by the PRMC Chair and/or Vice Chair. The remaining 112 studies, primarily representing SCCC investigator-initiated and industry-sponsored trials, were forwarded for full PRMC review. More than 70% of the studies reviewed by PRMC required modifications prior to being approved. No studies were disapproved. Ten underperforming studies were closed. In the next CCSG cycle, the PRMS will focus on further reduction in review timelines and enhancing information provided to investigators during the review process.
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0.993 |