The Chao Family Comprehensive Cancer Center (CFCCC) Protocol Review and Monitoring System isimplemented through the activities of its review committees and is supported and facilitated by administrativestaff. The system is designed to increase the translation of CFCCC discoveries from the laboratory into theclinic and improve the efficiency of opening and managing clinical trials. Proposed protocols are broughtforward by individual investigators to either a Disease-Oriented Team (DOT) or a correspondingmultidisciplinary tumor board. These groups are charged with determining their level of interest in andcommitment to the trial, whether the scientific question addressed is of sufficient importance to their field, theappropriateness of the trial design, the potential to accrue to the trial, any conflicts with existing studies andprioritization, and possible correlative translation science that could be captured. The principal charge of theProtocol Review and Monitoring Committee (PRMC) is evaluation of scientific quality and progress. Forscientific quality, the PRMC will evaluate only institutional, investigator-initiated trials (IITs) that have notundergone this process elsewhere. Cooperative group and pharmaceutical industry trials, which have beenvetted on a national level, are exempt from this review. In addition to scientific quality, the PRMC assesseswhether the clinical trials office has the appropriate resources (e.g. data management, pharmacy, nursing, etc.)to support the trial, how the trial fits into the broad interests of the Cancer Center (e.g. portfolio balance acrossdisease areas, potential for accrual of women and minorities, whether the trial is an IIT), and the track record ofthe principal investigator in accruing to previous trials. The PRMC will continue to routinely review scientificprogress for all open trials and also consider data timeliness and quality. The PRMC may disapprove a trial,approve a trial, or request additional information from the PI. The record of deliberations of the PRMC andcorrespondence with the PI is documented in the clinical trials management system, OnCore.
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