The Protocol Review and Monitoring System (PRMS) at Lombardi Comprehensive Cancer Center (LCCC) Is responsible for review of clinical cancer research protocols for scientific merit, ensuring prioritization of protocols based on scientific priorities and patient availability, allocating CCSG and institutional funds to support investigator-initiated trials and monitoring scientific progress. PRMS approval is required for all clinical cancer research studies at all MedStar hospitals. The function of the PRMS is independent ofthe role ofthe Institutional Review Board (IRB). Changes since the last submission include: 1) creation of a more robust cover sheet signed by the Disease Group Chair and PI that better documents prioritization of a specific trial relative to other trials and its importance to the disease and LCCC;2) development of a Scientific Progress Review Subcommittee (SPRC), chaired by Michael Atkins, MD, Deputy Director, charged with monitoring scientific progress and accrual of all open interventional studies;3) establishment of guidelines that encourage institutional studies be reviewed by the PRMS at the letter-of intent (LOI) stage with only approved LOIs developed into full protocols;4) the Resource Allocation Committee for Investigator Initiated Trials (RACIIT) chaired by Bruce Cheson MD, has been reorganized as a subcommittee of the PRMS, with meetings every 6 months to review approved LOIs requesting CCSG funding and/or institutional support;5) tightened administrative processes to ensure more complete minutes that include documentation of votes, conflicts of interest. Pi's response to all issues raised during PRMS review and accurate protocol versioning. While the focus ofthe PRMS is on institutional protocols, all clinical cancer studies (except for those involving healthy human subjects and/or population science studies deemed to be exempt by the Population Science Subcommittee of the PRMS) are reviewed by the PRMS. The PRMS comprises clinical Investigators from multiple MedStar Health hospitals, biostatisticians, basic scientists, population scientists, and translational researchers. Claudine Isaacs, MD, a medical oncologist and a breast cancer clinical investigator with a focus on treatment and prevention, has been Chair of the PRMS committee since 2006. Waddah Al-Refaie, MD, Chair of the Division of Surgical Oncology and a health services researcher assumed the vice-chair position in 2012. The PRMS reviewed and/or prioritized 190 clinical trials, including 34 institutional trials, over the past 3 years. In 2012, it deferred or disapproved 45% of newly submitted protocols, requiring further revision. In 2013 the SPRC performed an annual review and, based on this review, PRMS closed 16 protocols for lack of accrual or continued scientific relevance and recommended modification of 24 additional studies.

Public Health Relevance

This committee ensures that clinical trials carried out by LCCC investigators are scientifically rigorous, address current problems in cancer, and are feasible. This committee prioritizes trials for access to Center resources based on scientific merit, availability of patient and technical resources to efficiently complete trial objectives, fit with LCCC Research Program themes and overall Strategic Plan.

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National Cancer Institute (NCI)
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Subcommittee G - Education (NCI)
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Georgetown University
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