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.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Roswell Park Cancer Institute Corp
United States
Zip Code
Miller, James A; Harris, Kassem; Roche, Charles et al. (2018) Sarcopenia is a predictor of outcomes after lobectomy. J Thorac Dis 10:432-440
Fenstermaker, Robert A; Figel, Sheila A; Qiu, Jingxin et al. (2018) Survivin Monoclonal Antibodies Detect Survivin Cell Surface Expression and Inhibit Tumor Growth In Vivo. Clin Cancer Res 24:2642-2652
Bhat, Tariq A; Kalathil, Suresh Gopi; Bogner, Paul N et al. (2018) Secondhand Smoke Induces Inflammation and Impairs Immunity to Respiratory Infections. J Immunol 200:2927-2940
Qin, Bo; Llanos, Adana A M; Lin, Yong et al. (2018) Validity of self-reported weight, height, and body mass index among African American breast cancer survivors. J Cancer Surviv 12:460-468
Qiao, Guanxi; Chen, Minhui; Bucsek, Mark J et al. (2018) Adrenergic Signaling: A Targetable Checkpoint Limiting Development of the Antitumor Immune Response. Front Immunol 9:164
Merzianu, Mihai; Groman, Adrienne; Hutson, Alan et al. (2018) Trends in Bone Marrow Sampling and Core Biopsy Specimen Adequacy in the United States and Canada: A Multicenter Study. Am J Clin Pathol 150:393-405
Kumar, Sandeep; Inigo, Joseph R; Kumar, Rahul et al. (2018) Nimbolide reduces CD44 positive cell population and induces mitochondrial apoptosis in pancreatic cancer cells. Cancer Lett 413:82-93
Liu, Chunhong; Yu, Tao; Xing, Zhuo et al. (2018) Triplications of human chromosome 21 orthologous regions in mice result in expansion of megakaryocyte-erythroid progenitors and reduction of granulocyte-macrophage progenitors. Oncotarget 9:4773-4786
Muramatsu, Masashi; Akakura, Shin; Gao, Lingqiu et al. (2018) SSeCKS/Akap12 suppresses metastatic melanoma lung colonization by attenuating Src-mediated pre-metastatic niche crosstalk. Oncotarget 9:33515-33527
Gurova, Katerina; Chang, Han-Wen; Valieva, Maria E et al. (2018) Structure and function of the histone chaperone FACT - Resolving FACTual issues. Biochim Biophys Acta Gene Regul Mech :

Showing the most recent 10 out of 1555 publications