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
Ciamporcero, Eric; Miles, Kiersten Marie; Adelaiye, Remi et al. (2015) Combination strategy targeting VEGF and HGF/c-met in human renal cell carcinoma models. Mol Cancer Ther 14:101-10
Ma, Yingyu; Hu, Qiang; Luo, Wei et al. (2015) 1?,25(OH)2D3 differentially regulates miRNA expression in human bladder cancer cells. J Steroid Biochem Mol Biol 148:166-71
Shen, Li; Sundstedt, Anette; Ciesielski, Michael et al. (2015) Tasquinimod modulates suppressive myeloid cells and enhances cancer immunotherapies in murine models. Cancer Immunol Res 3:136-48
Adelaiye, Remi; Ciamporcero, Eric; Miles, Kiersten Marie et al. (2015) Sunitinib dose escalation overcomes transient resistance in clear cell renal cell carcinoma and is associated with epigenetic modifications. Mol Cancer Ther 14:513-22
Uekusa, Shota; Kawashima, Hiroyuki; Sugito, Kiminobu et al. (2014) Nr4a3, a possibile oncogenic factor for neuroblastoma associated with CpGi methylation within the third exon. Int J Oncol 44:1669-77
Ambrosone, Christine B; Zirpoli, Gary; Ruszczyk, Melanie et al. (2014) Parity and breastfeeding among African-American women: differential effects on breast cancer risk by estrogen receptor status in the Women's Circle of Health Study. Cancer Causes Control 25:259-65
Röhm, Marc; Grimm, Melissa J; D'Auria, Anthony C et al. (2014) NADPH oxidase promotes neutrophil extracellular trap formation in pulmonary aspergillosis. Infect Immun 82:1766-77
Rohrbach, Daniel J; Muffoletto, Daniel; Huihui, Jonathan et al. (2014) Preoperative mapping of nonmelanoma skin cancer using spatial frequency domain and ultrasound imaging. Acad Radiol 21:263-70
Ambrosone, Christine B; Young, Allyson C; Sucheston, Lara E et al. (2014) Genome-wide methylation patterns provide insight into differences in breast tumor biology between American women of African and European ancestry. Oncotarget 5:237-48
O'Brien, Shalana; Golubovskaya, Vita M; Conroy, Jeffrey et al. (2014) FAK inhibition with small molecule inhibitor Y15 decreases viability, clonogenicity, and cell attachment in thyroid cancer cell lines and synergizes with targeted therapeutics. Oncotarget 5:7945-59

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