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.

Public Health Relevance

Any clinical and translational trial with human participants must be held to the highest scientific and ethical standards. The PRMS assures that the standards are met and monitors accrual and progress in active trials. This work is highly relevant to the mission of the UAB Comprehensive Cancer Center and to NIH and the PHS.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA013148-42
Application #
8738178
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
42
Fiscal Year
2014
Total Cost
$177,235
Indirect Cost
$63,251
Name
University of Alabama Birmingham
Department
Type
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Nebane, N Miranda; Coric, Tatjana; McKellip, Sara et al. (2016) Acoustic Droplet Ejection Technology and Its Application in High-Throughput RNA Interference Screening. J Lab Autom 21:198-203
Zhang, Wei; Zhai, Ling; Wang, Yimin et al. (2016) Discovery of a novel inhibitor of kinesin-like protein KIFC1. Biochem J 473:1027-35
Carvajal, Felipe; Vallejos, Maricarmen; Walters, Beth et al. (2016) Structural domains within the HIV-1 mRNA and the ribosomal protein S25 influence cap-independent translation initiation. FEBS J 283:2508-27
Badiga, Suguna; Chambers, Michelle M; Huh, Warner et al. (2016) Expression of p16(INK4A) in cervical precancerous lesions is unlikely to be preventable by human papillomavirus vaccines. Cancer 122:3615-3623
Zhang, Wei; Zhai, Ling; Lu, Wenyan et al. (2016) Discovery of Novel Allosteric Eg5 Inhibitors Through Structure-Based Virtual Screening. Chem Biol Drug Des 88:178-87
Hull, Travis D; Boddu, Ravindra; Guo, Lingling et al. (2016) Heme oxygenase-1 regulates mitochondrial quality control in the heart. JCI Insight 1:e85817
Hegde, Shylaja; Kesterson, Robert A; Srivastava, Om P (2016) CRYβA3/A1-Crystallin Knockout Develops Nuclear Cataract and Causes Impaired Lysosomal Cargo Clearance and Calpain Activation. PLoS One 11:e0149027
Smith, M Ryan; Vayalil, Praveen K; Zhou, Fen et al. (2016) Mitochondrial thiol modification by a targeted electrophile inhibits metabolism in breast adenocarcinoma cells by inhibiting enzyme activity and protein levels. Redox Biol 8:136-48
McNally, Lacey R; Mezera, Megan; Morgan, Desiree E et al. (2016) Current and Emerging Clinical Applications of Multispectral Optoacoustic Tomography (MSOT) in Oncology. Clin Cancer Res 22:3432-9
Styles, Nathan A; Shonsey, Erin M; Falany, Josie L et al. (2016) Carboxy-terminal mutations of bile acid CoA:N-acyltransferase alter activity and substrate specificity. J Lipid Res 57:1133-43

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