Protocol Review and Monitoring

$191,502P30FY2014CANIH

University Of Alabama At Birmingham, Birmingham AL

Investigators

Linked publications & trials

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Abstract

The objective of the Protocol Review and Monitoring System (PRMS) of the Cancer Center is to fulfill the NCI mandate that the protocols for cancer clinical trials have scientific merit, that they meet the priorities of NCI, and that they progress. The PRMS is made up of the PRMS Office and the PRMS Committee. Its responsibilities include the scientific review of all interventional protocols (clinical trials) by the PRMS Committee which then makes recommendations for approval, approval with minor modifications, deferral for major modifications, or disapproval. The committee is composed of Cancer Center Director selected members representing expertise of the various oncology disciplines, laboratory research, basic science, cancer control/prevention, radiology, biostatistics, and research nursing. Written evaluation and recommendations of the committee accompany IRB applications on protocols approved by the PRMS. The PRMS Committee also reviews all active protocols annually in regard to patient accrual and progress and has the power to terminate any protocol that is not progressing. Over the past funding period, the PRMS has provided initial review of 304 protocols with 250 (82%) receiving approval (with or without minor revision) and 54 (18%) failing to receive approval including 47 (15%) receiving deferral and 7 (3%) receiving disapproval. Of the 47 protocols receiving deferral, 39 were granted approval on resubmission. The PRMS also provided administrative review of 76 national cooperative group trials with Disease Working Group support and recommendations. Over the past funding period, the PRMS provided annual review for accrual and progress of 254 active protocols. In the 2009 review for accrual and progress, the committee approved 27 protocols, placed 12 protocols on three or six month probation, and closed one protocol. The PRMS will continue rigorous review of Cancer Center protocols for scientific quality and Center priority as well as monitoring of accrual and progress of active protocols.

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