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 #
5P30CA006516-49
Application #
8601514
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-12-01
Budget End
2014-11-30
Support Year
49
Fiscal Year
2014
Total Cost
$271,681
Indirect Cost
$60,776
Name
Dana-Farber Cancer Institute
Department
Type
DUNS #
076580745
City
Boston
State
MA
Country
United States
Zip Code
02215
Lin, Ruei-Zeng; Lee, Chin Nien; Moreno-Luna, Rafael et al. (2017) Host non-inflammatory neutrophils mediate the engraftment of bioengineered vascular networks. Nat Biomed Eng 1:
Wang, Meng; Han, Jing; Marcar, Lynnette et al. (2017) Radiation Resistance in KRAS-Mutated Lung Cancer Is Enabled by Stem-like Properties Mediated by an Osteopontin-EGFR Pathway. Cancer Res 77:2018-2028
Ignatius, Myron S; Hayes, Madeline N; Lobbardi, Riadh et al. (2017) The NOTCH1/SNAIL1/MEF2C Pathway Regulates Growth and Self-Renewal in Embryonal Rhabdomyosarcoma. Cell Rep 19:2304-2318
Nugent, Alicia A; Park, Jong G; Wei, Yan et al. (2017) Mutant ?2-chimaerin signals via bidirectional ephrin pathways in Duane retraction syndrome. J Clin Invest 127:1664-1682
Breitkopf, Susanne B; Taveira, Mateus De Oliveira; Yuan, Min et al. (2017) Serial-omics of P53-/-, Brca1-/- Mouse Breast Tumor and Normal Mammary Gland. Sci Rep 7:14503
Bowden, John A; Heckert, Alan; Ulmer, Candice Z et al. (2017) Harmonizing lipidomics: NIST interlaboratory comparison exercise for lipidomics using SRM 1950-Metabolites in Frozen Human Plasma. J Lipid Res 58:2275-2288
Lindsley, R Coleman; Saber, Wael; Mar, Brenton G et al. (2017) Prognostic Mutations in Myelodysplastic Syndrome after Stem-Cell Transplantation. N Engl J Med 376:536-547
Mita, Monica M; Mita, Alain C; Moseley, Jennifer L et al. (2017) Phase 1 safety, pharmacokinetic and pharmacodynamic study of the cyclin-dependent kinase inhibitor dinaciclib administered every three weeks in patients with advanced malignancies. Br J Cancer 117:1258-1268
Hu, Yuebi; Alden, Ryan S; Odegaard, Justin I et al. (2017) Discrimination of Germline EGFR T790M Mutations in Plasma Cell-Free DNA Allows Study of Prevalence Across 31,414 Cancer Patients. Clin Cancer Res 23:7351-7359
Lam, Hilaire C; Liu, Heng-Jia; Baglini, Christian V et al. (2017) Rapamycin-induced miR-21 promotes mitochondrial homeostasis and adaptation in mTORC1 activated cells. Oncotarget 8:64714-64727

Showing the most recent 10 out of 371 publications