The Protocol Review and Monitoring System [PRMS] of the OSUCCC consists of a Clinical Scientific Review Committee [CSRC] that reviews all new cancer-related clinical protocols for scientific merit prior to IRB submission and monitors the scientific progress of ongoing studies including accrual rates. The CSRC is organized into two teams to permit a twice monthly meeting schedule and thereby facilitate rapid protocol review. The CSRC consists of 35 members representative of the 6 OSUCCC research programs. Its membership includes clinical and basic researchers, biostatisticians, pharmacists, and research nurses. At its bimonthly meetings, the CSRC performs full scientific reviews of all cancer-related clinical protocols initiated by local investigators or pharmaceutical industry sponsors. CSRC approval of a protocol is required prior to its review by the OSU Cancer Institutional Review Board. Each protocol is reviewed by three CSRC members, one of whom must be a biostatistician, in addition to pharmacy review. Reviewers follow a written review template that calls for an analysis of the scientific hypothesis and rationale, experimental design, patient inclusion and exclusion criteria, treatment plan, and statistical considerations. As of January 2009, all new research protocols undergo review by the CSRC Feasibility Review Committee (FRC), which is a subcommittee of the CSRC. The FRC was implemented to facilitate trial activation and confirm proper prioritization. The FRC does not evaluate the scientific aspects of the protocol, which is left to the CSRC parent committee, but instead evaluates the availability of those resources necessary to implement the protocol. The CSRC Executive Committee (EC) provides oversight to the CSRC. It consists of seven CSRC members that meets monthly to assign new submissions to members for review, to review protocol accrual and ensure that protocol prioritization rules are followed. The CSRC adheres to a set of well-defined criteria for accrual monitoring and trial prioritization. Those ongoing studies that do not show adequate accrual or fail to meet accepted standards of quality control based on formal audits are terminated. In 2009, 8 trials were closed for low accrual: 2 by the PI and 6 by the CSRC. The EC can also perform expedited reviews for appropriate studies (e.g., retrospective reviews). In 2009, 176 new protocols were reviewed by the CSRC with the following results: 32 (18%) were approved as written, 64 (37%) were approved with stipulations, 20 (11%) were deferred, 3 (2%) were withdrawn and 57 (32%) protocols that received outside scientific review were acknowledged. Twenty-eight non-interventional protocols were also approved In an expedited fashion by the CSRC EC.

Public Health Relevance

The Clinical Scientific Review Committee comprises the The Protocol Review and Monitoring System of the OSUCCC and thus reviews the scientific progress of cancer-related protocols and their ability to accrue. This mechanism ensures that clinical science being conducted at the OSUCCC is scientifically sound.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA016058-38
Application #
8601838
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-12-01
Budget End
2014-11-30
Support Year
38
Fiscal Year
2014
Total Cost
$45,465
Indirect Cost
$15,651
Name
Ohio State University
Department
Type
DUNS #
832127323
City
Columbus
State
OH
Country
United States
Zip Code
43210
Fazio, Nicola; Buzzoni, Roberto; Baudin, Eric et al. (2016) A Phase II Study of BEZ235 in Patients with Everolimus-resistant, Advanced Pancreatic Neuroendocrine Tumours. Anticancer Res 36:713-9
Eloy, Josimar O; Petrilli, Raquel; Topan, José Fernando et al. (2016) Co-loaded paclitaxel/rapamycin liposomes: Development, characterization and in vitro and in vivo evaluation for breast cancer therapy. Colloids Surf B Biointerfaces 141:74-82
Byrd, John C; Flynn, Joseph M; Kipps, Thomas J et al. (2016) Randomized phase 2 study of obinutuzumab monotherapy in symptomatic, previously untreated chronic lymphocytic leukemia. Blood 127:79-86
Datta, Jharna; Islam, Mozaffarul; Dutta, Samidha et al. (2016) Suberoylanilide hydroxamic acid inhibits growth of head and neck cancer cell lines by reactivation of tumor suppressor microRNAs. Oral Oncol 56:32-9
Wang, Hai; Agarwal, Pranay; Zhao, Shuting et al. (2016) Combined cancer therapy with hyaluronan-decorated fullerene-silica multifunctional nanoparticles to target cancer stem-like cells. Biomaterials 97:62-73
Villalona-Calero, Miguel A; Duan, Wenrui; Zhao, Weiqiang et al. (2016) Veliparib Alone or in Combination with Mitomycin C in Patients with Solid Tumors With Functional Deficiency in Homologous Recombination Repair. J Natl Cancer Inst 108:
Rai, K; Pilarski, R; Cebulla, C M et al. (2016) Comprehensive review of BAP1 tumor predisposition syndrome with report of two new cases. Clin Genet 89:285-94
Kerrigan, Kathleen; Shoben, Abigail; Otterson, Gregory (2016) Treatment of Lung Cancer Patients With Actionable Mutations in the Intensive Care Unit. Clin Lung Cancer 17:523-527
DiSilvestro, David J; Melgar-Bermudez, Emiliano; Yasmeen, Rumana et al. (2016) Leptin Production by Encapsulated Adipocytes Increases Brown Fat, Decreases Resistin, and Improves Glucose Intolerance in Obese Mice. PLoS One 11:e0153198
Terakawa, Jumpei; Rocchi, Altea; Serna, Vanida A et al. (2016) FGFR2IIIb-MAPK Activity Is Required for Epithelial Cell Fate Decision in the Lower Müllerian Duct. Mol Endocrinol 30:783-95

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