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.
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.
|Carson, Tiffany L; Hardy, Claudia M; Greene, Eva et al. (2014) Considerations for bio-specimen collection among black women residing in the rural Deep South participating in a cancer prevention study. J Community Genet 5:257-63|
|Fauci, Janelle M; Sabbatino, Francesco; Wang, Yangyang et al. (2014) Monoclonal antibody-based immunotherapy of ovarian cancer: targeting ovarian cancer cells with the B7-H3-specific mAb 376.96. Gynecol Oncol 132:203-10|
|Devine, D J; Rostas, J W; Metge, B J et al. (2014) Loss of N-Myc interactor promotes epithelial-mesenchymal transition by activation of TGF-*/SMAD signaling. Oncogene 33:2620-8|
|Kim, Hyunki; Rigell, Christopher J; Zhai, Guihua et al. (2014) Antagonistic effects of anti-EMMPRIN antibody when combined with chemotherapy against hypovascular pancreatic cancers. Mol Imaging Biol 16:85-94|
|Saini, Reshu; Hoyt, Kenneth (2014) Recent developments in dynamic contrast-enhanced ultrasound imaging of tumor angiogenesis. Imaging Med 6:41-52|
|Sonpavde, Guru; Willey, Christopher D; Sudarshan, Sunil (2014) Fibroblast growth factor receptors as therapeutic targets in clear-cell renal cell carcinoma. Expert Opin Investig Drugs 23:305-15|
|Shim, Eun-Hee; Livi, Carolina B; Rakheja, Dinesh et al. (2014) L-2-Hydroxyglutarate: an epigenetic modifier and putative oncometabolite in renal cancer. Cancer Discov 4:1290-8|
|Gan, Yujun; Buckels, Ashiya; Liu, Ying et al. (2014) Human GH receptor-IGF-1 receptor interaction: implications for GH signaling. Mol Endocrinol 28:1841-54|
|Johnson, David H; Wilson, W William; DeLucas, Lawrence J (2014) Protein solubilization: a novel approach. J Chromatogr B Analyt Technol Biomed Life Sci 971:99-106|
|Ramos, Theresa N; Bullard, Daniel C; Barnum, Scott R (2014) ICAM-1: isoforms and phenotypes. J Immunol 192:4469-74|
Showing the most recent 10 out of 364 publications