The Clinical Research Committee (CRC) at the Lombardi Comprehensive Cancer Center (Lombardi) is responsible for the review of clinical cancer research protocols for scientific merit, ensures prioritization of protocols based upon scientific priorities and patient availability, and monitors scientific progress of cancer protocols. CRC approval is required for institutional cancer treatment protocols to gain access to Lombardi's CCSG-supported resources. Additionally, since the last submission, the CRC has expanded to include review of all cancer treatment protocols being carried out at all the MedStar Health network hospitals and representatives from these institutions are now members of the CRC. While the focus of the CRC is on institutional protocols, all studies (except for those that do not involve a cancer therapy for a cancer patient population and cooperative group studies with central Institutional Review Board [IRB] approval) are reviewed by the CRC. The CRC is composed of clinical investigators, biostatisticians, a population scientist and several translational researchers. Claudine Isaacs, MD, a member of the CRC, assumed the position of Clinical Co- Chair of the Committee. Together with William Waterfield, MD, the Co-Chair, the chairs direct the administrative functions of the CRC, with the support of an administrative coordinator. Responsibilities of the Co-Chairs include the review of the protocols before, during, and after the monthly CRC meeting (to determine whether modifications to protocols have been appropriately implemented), assignment of appropriate reviewers for each submitted protocol, development of a monthly agenda, completion of meeting minutes, review of assignments, and supervision of the administrative functions required to support the CRC. The function of the CRC is independent of the role of the IRB. The priority of the CRC is to ensure quality in the design and conduct of Lombardi protocols, while the priority of the IRB is to ensure protection of human subjects. The purpose of the IRB is to monitor research involving human subjects, assure compliance with the Food and Drug Administration (FDA) and the Department of Health and Human Services regulations and ensure the protection of the rights and welfare of human subjects. The CRC evaluates the scientific merit of a protocol, ensures prioritization of protocols based on scientific priorities and patient availability, and monitors scientific progress of cancer protocols. The CRC also reviews all consent forms to ensure that they adequately and accurately reflect the science of the protocol. As part of the initial scientific review, the CRC also identifies protocols that need institutional data and safety monitoring oversight and specifies study elements to be monitored. Operating in conjunction with the CRC, the Data and Safety Monitoring Committee (DSMC) monitors the elements identified by the CRC.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA051008-19
Application #
8375527
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
2014-04-30
Budget Start
2012-05-01
Budget End
2013-04-30
Support Year
19
Fiscal Year
2012
Total Cost
$16,564
Indirect Cost
Name
Georgetown University
Department
Type
DUNS #
049515844
City
Washington
State
DC
Country
United States
Zip Code
20057
Kim, Sang-Soo; Rait, Antonina; Garrido-Sanabria, Emilio R et al. (2018) Nanotherapeutics for Gene Modulation that Prevents Apoptosis in the Brain and Fatal Neuroinflammation. Mol Ther 26:84-94
Taylor, Teletia R; Dash, Chiranjeev; Sheppard, Vanessa et al. (2018) The effect of a randomized controlled physical activity trial on health related quality of life in metabolically unhealthy African-American women: FIERCE STUDY. Contemp Clin Trials 67:121-128
O'Neill, Suzanne C; Evans, Chalanda; Hamilton, Rebekah J et al. (2018) Information and support needs of young women regarding breast cancer risk and genetic testing: adapting effective interventions for a novel population. Fam Cancer 17:351-360
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Pannkuk, Evan L; Laiakis, Evagelia C; Garcia, Melissa et al. (2018) Nonhuman Primates with Acute Radiation Syndrome: Results from a Global Serum Metabolomics Study after 7.2 Gy Total-Body Irradiation. Radiat Res :
Ahn, Jaeil; Conkright, Brian; Boca, Simina M et al. (2018) POPSTR: Inference of Admixed Population Structure Based on Single-Nucleotide Polymorphisms and Copy Number Variations. J Comput Biol 25:417-429
Ujjani, Chaitra; Wang, Hongkun; Skarbnik, Alan et al. (2018) A phase 1 study of lenalidomide and ibrutinib in combination with rituximab in relapsed and refractory CLL. Blood Adv 2:762-768
Chang, Joanne T; Levy, David T; Meza, Rafael (2018) Examining the Transitions Between Cigarette and Smokeless Tobacco Product Use in the United States Using the 2002-2003 and 2010-2011 Longitudinal Cohorts. Nicotine Tob Res 20:1412-1416
Naab, Tammey J; Gautam, Anita; Ricks-Santi, Luisel et al. (2018) MYC amplification in subtypes of breast cancers in African American women. BMC Cancer 18:274
Alamri, Ahmad M; Liu, Xuefeng; Blancato, Jan K et al. (2018) Expanding primary cells from mucoepidermoid and other salivary gland neoplasms for genetic and chemosensitivity testing. Dis Model Mech 11:

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