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. This system includes: 1) a single Protocol Review and Monitoring System (PRMS);2) a unified data and safety monitoring process (DSMP);3) a common IRB for review of cancer-relevant research;and 4) a centralized infrastructure to support DF/HCC clinical research that is composed of the Protocol Review Office (PRO), Clinical Research Unit (CRU), Biostatistics Core and Protocol-Specific Research Support (PSRS) and other relevant offices. Unified clinical trials informatics for the consortium is managed by the clinical trials informatics team in the CRU. Effective and timely communication and coordination are achieved through strong faculty and administrative leadership, consortium-wide operating policies and procedures and inter-institutional clinical trials committees. Faculty and staff training in the conduct of clinical trials is managed by the CRU's educational team. There is ongoing monitoring of the Center's clinical trials operations by the Executive Committee, external advisors and the External Advisory Board. The 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 PRMS received conditional approval at the time of the last CCSG renewal and was awarded full approval in 2006. Concurrently, the Center Director tasked the Associate Director for Administration and the Medical Director of Clinical Trials Operations to lead a comprehensive clinical trials improvement project. This resulted in major enhancements to all aspects of clinical trials operations including quality, conduct, oversight and improvement in review turn around time.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA006516-47
Application #
8228414
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2012-05-15
Budget End
2012-11-30
Support Year
47
Fiscal Year
2012
Total Cost
$306,976
Indirect Cost
$69,347
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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