The Roswell Park Cancer Institute (RPCI) Protocol Review and Monitoring System is under the direct responsibility of Alex A. Adjei MD, PhD, Associate Director for Clinical Research with administrative support provided by Joyce Yasko PhD, Administrative Director, and Laurie Musial RN, MS, CCRP, Administrative Co-Director. Dr. Yasko and Ms. Musial oversee daily operations of the PRMS components, which include the Clinical Research Feasibility and Prioritization Committee (CRPC), the Scientific Review Committee (SRC), the Response Review Committee (RRC), the Phase I Committee, and the Clinical Research Management System (CRMS). The CRPC was established in 2007 to enhance the process of study protocol development;to ensure that only high quality clinical research studies are performed, to optimize collaboration among RPCI investigators and to monitor RPCI resource utilization. All RPCI sponsored clinical research studies utilizing RPCI resources are reviewed at the concept stage (Investigator-Initiated) or study protocol stage (Industry Sponsored or National Cooperative Groups) to ensure a cohesive institution-wide clinical research program. CRPC approval must be obtained before a study is allowed to progress to SRC review and approval. All RPCI sponsored clinical research studies are reviewed by the SRC prior to submission to the IRB. The scope of SRC responsibilities includes review and approval or disapproval of new and ongoing clinical research studies, study amendments, monitoring reports, and corrective actions of non-accruing and slow accruing studies. The SRC reviews new studies to ensure that scientific content and study design are appropriate, that they are prioritized based on scientific resources, they are appropriately prioritized, and that there is statistical oversight in place. The RRC is charged with reviewing radiological responses of intervention studies and the Phase I Committee is charged with reviewing all aspects of institutional Phase I studies, respectively. The RRC reports outcomes to the SRC and the Data and Safety Monitoring Board, while the Phase I Committee reports findings to the IRB. The CRMS is the electronic database developed to provide management, capture and track all RPCI clinical research studies and their activity. The CRMS electronically monitors RPCI studies from initial submission, through the SRC and IRB review and approval process, through the study implementation process, until study termination. The Clinical and Protocol Data Management Services (CPDM) uses CRMS to manage over 2000 studies.

Public Health Relevance

Clinical research is essential to translating outstanding basic science into clinical care. The PRMS function ensures that only high quality;high priority cancer clinical research studies are conducted to maximize efficient and effective use of patient and Institute resources.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA016056-37
Application #
8738374
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-06-16
Project End
2019-04-30
Budget Start
2014-06-26
Budget End
2015-04-30
Support Year
37
Fiscal Year
2014
Total Cost
$108,756
Indirect Cost
$43,017
Name
Roswell Park Cancer Institute Corp
Department
Type
DUNS #
824771034
City
Buffalo
State
NY
Country
United States
Zip Code
14263
Block, Matthew S; Vierkant, Robert A; Rambau, Peter F et al. (2018) MyD88 and TLR4 Expression in Epithelial Ovarian Cancer. Mayo Clin Proc 93:307-320
Li, Qiuhui; Deng, Qu; Chao, Hsueh-Ping et al. (2018) Linking prostate cancer cell AR heterogeneity to distinct castration and enzalutamide responses. Nat Commun 9:3600
Rossetti, Stefano; Wierzbicki, Andrzej J; Sacchi, Nicoletta (2018) Undermining ribosomal RNA transcription in both the nucleolus and mitochondrion: an offbeat approach to target MYC-driven cancer. Oncotarget 9:5016-5031
Mett, V; Komarova, E A; Greene, K et al. (2018) Mobilan: a recombinant adenovirus carrying Toll-like receptor 5 self-activating cassette for cancer immunotherapy. Oncogene 37:439-449
Long, Mark D; Singh, Prashant K; Russell, James R et al. (2018) The miR-96 and RAR? signaling axis governs androgen signaling and prostate cancer progression. Oncogene :
Kawaguchi, Tstutomu; Yan, Li; Qi, Qianya et al. (2018) Novel MicroRNA-Based Risk Score Identified by Integrated Analyses to Predict Metastasis and Poor Prognosis in Breast Cancer. Ann Surg Oncol 25:4037-4046
Vexler, Albert; Yu, Jihnhee; Zhao, Yang et al. (2018) Expected p-values in light of an ROC curve analysis applied to optimal multiple testing procedures. Stat Methods Med Res 27:3560-3576
Mussell, Ashley L; Denson, Kayla E; Shen, He et al. (2018) Loss of KIBRA function activates EGFR signaling by inducing AREG. Oncotarget 9:29975-29984
Hirose, Yuki; Nagahashi, Masayuki; Katsuta, Eriko et al. (2018) Generation of sphingosine-1-phosphate is enhanced in biliary tract cancer patients and is associated with lymphatic metastasis. Sci Rep 8:10814
Kesterson, Joshua P; Szender, J Brian; Schaefer, Eric et al. (2018) Evaluation of Association Between Gynecologic Oncology Fellowship Length and a Career in Academic Medicine. J Cancer Educ 33:141-146

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