Dana-Farber/Harvard Cancer Center (DF/HCC) has a well-developed system for the review, oversight and support of cancer-relevant protocols, regardless of the source of support, which are developed and conducted at DF/HCC member institutions. The foundations of the centralized infrastructure include: (1) a single Protocol Review and Monitoring System (PRMS); (2) a unified data and safety monitoring process (DSMP); (3) a common institutional review board system (IRB) for review of cancer-relevant research; and (4) shared access to various DF/HCC cores and programs including but not limited to the Biostatistics Core and Early Phase Clinical Research Support (EPCRS). Unified clinical trials informatics for the consortium is managed by Clinical Protocol and Data Management (CPDM). This consolidated data management functions of the office formerly known as the Quality Assurance Office for Clinical Trials with the research informatics function. The Protocol Review and Monitoring System (PRMS) focuses on the scientific merit of protocols, prioritization and feasibility of trial completion. All proposed cancer-relevant research at member institutions must be reviewed and approved by a Scientific Review Committee (SRC) or through expedited administrative scientific review, as permitted by the CCSG for peer-reviewed research, and, on an annual basis, reviewed by the Scientific Progress Review Committee (SPRC). The Office for Human Research Studies (OHRS) manages the operations of the PRMS. Since 2005, the PRMS has been under the direction of Michele Russell-Einhorn, JD, who reports to Drew Memmott, the Associate Director for Administration of DF/HCC. The PRMS received full approval in 2011.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA006516-52
Application #
9208413
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2016-12-01
Budget End
2017-11-30
Support Year
52
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Dana-Farber Cancer Institute
Department
Type
DUNS #
076580745
City
Boston
State
MA
Country
United States
Zip Code
02215
Hu, Yanhui; Comjean, Aram; Roesel, Charles et al. (2016) FlyRNAi.org-the database of the Drosophila RNAi screening center and transgenic RNAi project: 2017 update. Nucleic Acids Res :
Hong, Theodore S; Wo, Jennifer Y; Yeap, Beow Y et al. (2016) Multi-Institutional Phase II Study of High-Dose Hypofractionated Proton Beam Therapy in Patients With Localized, Unresectable Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma. J Clin Oncol 34:460-8
Freedman, Rachel A; Gelman, Rebecca S; Wefel, Jeffrey S et al. (2016) Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer and Brain Metastases. J Clin Oncol 34:945-52
Mohr, Stephanie E; Hu, Yanhui; Ewen-Campen, Benjamin et al. (2016) CRISPR guide RNA design for research applications. FEBS J 283:3232-8
Brunner, Andrew M; Li, Shuli; Fathi, Amir T et al. (2016) Haematopoietic cell transplantation with and without sorafenib maintenance for patients with FLT3-ITD acute myeloid leukaemia in first complete remission. Br J Haematol 175:496-504
Cox, Andrew G; Hwang, Katie L; Brown, Kristin K et al. (2016) Yap reprograms glutamine metabolism to increase nucleotide biosynthesis and enable liver growth. Nat Cell Biol 18:886-96
McKay, Tina B; Hjortdal, Jesper; Sejersen, Henrik et al. (2016) Endocrine and Metabolic Pathways Linked to Keratoconus: Implications for the Role of Hormones in the Stromal Microenvironment. Sci Rep 6:25534
Nelms, Bradlee D; Waldron, Levi; Barrera, Luis A et al. (2016) CellMapper: rapid and accurate inference of gene expression in difficult-to-isolate cell types. Genome Biol 17:201
Tan, Justin L; Fogley, Rachel D; Flynn, Ryan A et al. (2016) Stress from Nucleotide Depletion Activates the Transcriptional Regulator HEXIM1 to Suppress Melanoma. Mol Cell 62:34-46
Johnson, Shawn F; Cruz, Cristina; Greifenberg, Ann Katrin et al. (2016) CDK12 Inhibition Reverses De Novo and Acquired PARP Inhibitor Resistance in BRCA Wild-Type and Mutated Models of Triple-Negative Breast Cancer. Cell Rep 17:2367-2381

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