The Protocol Review and Monitoring System (PRMS) was first implemented in the early 1990s to oversee scientific cancer research involving cancer patients in the facilities of the institutions that define the Karmanos Cancer Institute. The main objectives of the monitoring system include the following: 1) review the scientific merit of cancer research protocols; 2) ensure prioritization of therapeutic cancer protocols according to KCIs scientific priorities; 3) monitor scientific progress. The committee is composed of a complementary mix of senior and junior investigators from various disciplines, and specialities, as well as representatives from the Biostatistical Core, nursing and physician extenders, and administrative support staff from the CTO. The members of the committee represent a sufficient size, and breadth of expertise to conduct a critical, fair scientific review of all clinical research protocols involving cancer patients in the institutions comprising the Cancer Center. The PRMS provides internal oversight of the scientific and research aspects of the cancer trials, in addition to assuring that its clinical resources are engaged to ensure the best practices for scientific endeavors and applications. The function of the PRMS is complementary to that of the Institutional Review Board, which focuses on the protection of human subjects. The PRMS is not intended to duplicate or overlap the responsibilities of the IRB, nor is it intended to perform an auditing or data and safety monitoring function. The PRMS evaluates all cancer clinical trials, whether derived and supported from institutional sources or from industry. However, the PRMS does not duplicate the results of traditional peer review, which includes protocols supported by various NIH mechanisms (e.g., R01s, U01s, P01s, U10s and P50s), and clinical research protocols approved by the NCI's Cancer Therapy Evaluation Program. Scientific review takes into account the specific rationale, study design, duplication of studies already in progress elsewhere, adequacy of biostatistical input, and feasibility for completion of the study within a reasonable time frame.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA022453-25
Application #
7310833
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
25
Fiscal Year
2006
Total Cost
$37,518
Indirect Cost
Name
Wayne State University
Department
Type
DUNS #
001962224
City
Detroit
State
MI
Country
United States
Zip Code
48202
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