The RPCI Clinical Protocol and Data Management/Clinical Trials Office (CPDM) is a comprehensive resource that provides a full range of clinical research services for all RPCI investigators at all RPCI clinical sites and in the clinical sites of its affiliates. CPDM is directed by Joyce Yasko, PhD, with Assistant Director Laurie Musial RN, MS and overseen by Alex Adjei, MD, PhD, Associate Director for Clinical Research. CPDM provides resources and oversight for the development, review, implementation, and conduct of clinical research studies and tracks regulatory documents. In collaboration with the study principal investigator, CPDM submits studies and amendments to the Scientific Review Committee (SRC) and Institutional Review Board (IRB) and submits continuing reviews to the IRB. CPDM also provides administrative support for the Clinical Research Prioritization and Feasibility Committee (CRPC), Scientific Review Committee (SRC), Response Review Committee (RRC), Phase I Committee and the Data and Safety Monitoring Board (DSMB). CPDM prepares, negotiates and manages study budgets and contracts; provides study sponsors and regulatory agencies with all required study documents;coordinates the conduct of all RPCI clinical studies and ensures that complete and accurate study data are collected and entered into a centralized electronic research database (eClinical). CPDM also ensures that all adverse events are reported promptly and accurately. In CY 2012, CPDM managed 213 active intervention studies with an accrual of 870 participants (1235 consented accrual) and 256 non-intervention studies with an accrual of 591,727 participants. The RPCI Data &Safety Monitoring Board (DSMB) coordinates and provides oversight for data and safety monitoring for all treatment intervention studies consistent with the NIH Policy for Data and Safety Monitoring dated June 10, 1998. The revised Roswell Park Cancer Institute Data &Safety Monitoring Plan (DSMP) was approved by the National Cancer Institute on April 4, 2011

Public Health Relevance

The Clinical Protocol and Data Management (CPDM) office provides the necessary infrastructure to conduct clinical investigations and to translate the basic research at Roswell Park Cancer Institute into cancer-relevant clinical studies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA016056-37
Application #
8738372
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
$231,955
Indirect Cost
$91,748
Name
Roswell Park Cancer Institute Corp
Department
Type
DUNS #
824771034
City
Buffalo
State
NY
Country
United States
Zip Code
14263
La Shu, Shin; Yang, Yunchen; Allen, Cheryl L et al. (2018) Metabolic reprogramming of stromal fibroblasts by melanoma exosome microRNA favours a pre-metastatic microenvironment. Sci Rep 8:12905
Mayor, Paul C; Eng, Kevin H; Singel, Kelly L et al. (2018) Cancer in primary immunodeficiency diseases: Cancer incidence in the United States Immune Deficiency Network Registry. J Allergy Clin Immunol 141:1028-1035
Dasgupta, Subhamoy; Rajapakshe, Kimal; Zhu, Bokai et al. (2018) Metabolic enzyme PFKFB4 activates transcriptional coactivator SRC-3 to drive breast cancer. Nature 556:249-254
Ma, Wen Wee; Xie, Hao; Fetterly, Gerald et al. (2018) A Phase Ib Study of the FGFR/VEGFR Inhibitor Dovitinib With Gemcitabine and Capecitabine in Advanced Solid Tumor and Pancreatic Cancer Patients. Am J Clin Oncol :
Zhang, Dingxiao; Tang, Dean G; Rycaj, Kiera (2018) Cancer stem cells: Regulation programs, immunological properties and immunotherapy. Semin Cancer Biol 52:94-106
Gabriel, Emmanuel; Attwood, Kristopher; Al-Sukhni, Eisar et al. (2018) Age-related rates of colorectal cancer and the factors associated with overall survival. J Gastrointest Oncol 9:96-110
Barger, Carter J; Zhang, Wa; Sharma, Ashok et al. (2018) Expression of the POTE gene family in human ovarian cancer. Sci Rep 8:17136
Chen, George L; Carpenter, Paul A; Broady, Raewyn et al. (2018) Anti-Platelet-Derived Growth Factor Receptor Alpha Chain Antibodies Predict for Response to Nilotinib in Steroid-Refractory or -Dependent Chronic Graft-Versus-Host Disease. Biol Blood Marrow Transplant 24:373-380
Eng, Kevin H; Szender, J Brian; Etter, John Lewis et al. (2018) Paternal lineage early onset hereditary ovarian cancers: A Familial Ovarian Cancer Registry study. PLoS Genet 14:e1007194
Tubbs, Anthony; Sridharan, Sriram; van Wietmarschen, Niek et al. (2018) Dual Roles of Poly(dA:dT) Tracts in Replication Initiation and Fork Collapse. Cell 174:1127-1142.e19

Showing the most recent 10 out of 1555 publications