Winship's Protocol Review and Monitoring System (PRMS) requires the review of all proposed cancer clinical trials for scientific quality and merit. The PRMS also calls for the prioritization, monitoring, and termination of protocols based on scientific progress and patient accrual. The Winship Clinical and Translational Review Committee (CTRC) is responsible for these functions. The CTRCs purposes are: 1. To review new proposals for clinical research to ensure that they are scientifically meritorious, that they address significant scientific issues, and that there are sufficient patient and institutional resources to conduct the study as proposed. 2. To prioritize among clinical research proposals within cancer disease sites in order to best fulfill the strategic objectives of the Winship Cancer Institute and of its four research programs. 3. To review the scientific progress of existing clinical research protocols and to terminate protocols in which accrual rates are inconsistent with meeting the stated scientific objective or in which new scientific data renders the trial as having greater safety or efficacy issues or as less scientifically important. 4. To monitor studies for the accuracy and validity of the clinical and laboratory data obtained during the conduct of the clinical study. PRMS is now clearly separated from the Winship Clinical Trials Office (CTO) and the Data Safety and Monitoring Plan (DSMP). In addition, the CTRC has tightened the criteria for new study proposals to achieve scientific review. The changes in criteria include: 1) strict rules regarding the ability of new studies to meet accrual targets, with special attention to any potential eligibility conflict with any ongoing clinical trials, and 2) a requirement that new study proposals address scientific questions relevant to the Winship Cancer Institute's overall scientific goals. The CTRC, under the direction of Thomas Olson, M.D. and Taofeek Owonikoko, Ph.D., M.D expanded to include 24 members and meets on a twice monthly basis to review all proposed cancer clinical trials.

Public Health Relevance

The Protocol Review and Monitoring System (PRMS) ensures that all cancer-related clinical research studies Involving human subjects that are conducted at the Winship Cancer Institute are scientifically evaluated and prioritized.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA138292-06
Application #
8634054
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
6
Fiscal Year
2014
Total Cost
$34,360
Indirect Cost
$12,334
Name
Emory University
Department
Type
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322
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