The Protocol Review and Monitoring Committee (PRMC) was established in 1991 at UHC. In July 2004, a joint PRMCcomprised of 49 members (31 from Case/UHC; 16 from CCF/CCLCM; and 2 patient advocates) from the partnerinstitutions of the Case Comprehensive Cancer Center was implemented, in which all cancer protocols are reviewed inpartnership for scientific merit and prioritization. The PRMC serves as the focal point for the assessment of all newtherapeutic clinical trials at the Case Comprehensive Cancer Center by providing protocol review (and associatedfeedback to assist protocol development), and scientific monitoring. The Committee considers new concepts [letters ofintent (LOIs)] submitted by individual investigators, reviews new protocols and amendments, receives adverse eventsand clinical responses, and monitors the scientific progress of active studies. While the emphasis is on thedevelopment, review, and approval of investigator-initiated clinical trials and protocol concepts, all therapeutic trials arereviewed by this committee including NCI-sponsored (e.g., R21, R01 and U01/N01), cooperative group (e.g., ECOG,SWOG, RTOG, NSABP, GOG and others), pharmaceutical, and multi-institutional consortium studies. The PRMC alsoreviews behavioral and observational trials on cancer patients. Institutional commitment to this charge is indicated by adirective from both UHC and CCF Chiefs of Staff, that all clinical trials for patients with cancer be reviewed by thisCommittee prior to review by the Case Cancer IRB. The PRMC does not engage in primary safety monitoring orauditing of data. However, it does receive data safety and toxicity reports, clinical response reports, and qualityassurance reports generated by: (1) the Clinical Trials Unit (CTU) audit systems and other audit reports (e.g., NCI,cooperative group, pharmaceutical sponsor); (2) the Patient Protocol Review Committees for Phase I trials (Dr. Dowlati,Chair), and the stem cell therapies and acute leukemia trials (Dr. Laughlin, Chair); and (3) the Cancer Center DataSafety and Toxicity Committee (DSTC, Dr. B. Cooper, Chair). The Committee also closely interacts with Clinical TrialsDisease Teams, where initial pre-review for all therapeutic trials is undertaken. The teams provide pre-review byexperts in their field for scientific merit, prioritization, and intent to accrue patients. Interactive Clinical Trials DiseaseTeams with respective co-leaders at each partner institution were established by the Cancer Center for directing theclinical trials research agenda for each team. The co-leaders are charged with setting a single research agenda,identifying new studies for activation, and making recommendations to the PRMC. The senior leadership identified thisas an important strategy to build advocacy for any given trial at the physician-investigator level and to charge the teamswith driving their respective trials agenda in order to grow the partnership. This strategy was fully endorsed by ourexternal advisors. The Committee is comprised of clinical investigators in all cancer modalities, laboratory scientists,biostatisticians, and patient advocates. CCSG support for a total of 1.10 FTE is requested for the Chair (Dr. Sagar,0.025 FTE), the 3 co-chairs (Drs. Budd, Lazarus and Waggoner, each at 0.025 FTE), and the Administrative Director(Ms. Naser, 1.0 FTE). Recommendations for scientific merit and priority for accrual are directly communicated to theCase Cancer IRB
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