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
Rao, Guanhua; Pierobon, Mariaelena; Kim, In-Kyu et al. (2017) Inhibition of AKT1 signaling promotes invasion and metastasis of non-small cell lung cancer cells with K-RAS or EGFR mutations. Sci Rep 7:7066
Smith, Jill P; Wang, Shangzi; Nadella, Sandeep et al. (2017) Cholecystokinin receptor antagonist alters pancreatic cancer microenvironment and increases efficacy of immune checkpoint antibody therapy in mice. Cancer Immunol Immunother :
Vietsch, Eveline E; Graham, Garrett T; McCutcheon, Justine N et al. (2017) Circulating cell-free DNA mutation patterns in early and late stage colon and pancreatic cancer. Cancer Genet 218-219:39-50
Lynce, Filipa; Barac, Ana; Tan, Ming T et al. (2017) SAFE-HEaRt: Rationale and Design of a Pilot Study Investigating Cardiac Safety of HER2 Targeted Therapy in Patients with HER2-Positive Breast Cancer and Reduced Left Ventricular Function. Oncologist 22:518-525
Walker, Logan C; Marquart, Louise; Pearson, John F et al. (2017) Evaluation of copy-number variants as modifiers of breast and ovarian cancer risk for BRCA1 pathogenic variant carriers. Eur J Hum Genet 25:432-438
Zhang, Yong-Wei; Nasto, Rochelle E; Jablonski, Sandra A et al. (2017) RNA Interference Screening to Identify Proliferation Determinants in Breast Cancer Cells. Bio Protoc 7:
DeVito, Stephen; Woodrick, Jordan; Song, Linze et al. (2017) Mutagenic potential of hypoxanthine in live human cells. Mutat Res 803-805:9-16
Wang, Hongkun; Wang, Ying; Kota, Krishna K et al. (2017) Strong associations between chromosomal aberrations in blood lymphocytes and the risk of urothelial and squamous cell carcinoma of the bladder. Sci Rep 7:13493
Parodi, Daniela A; Greenfield, Morgan; Evans, Claire et al. (2017) Alteration of Mammary Gland Development and Gene Expression by In Utero Exposure to Cadmium. Int J Mol Sci 18:
Casero, David; Gill, Kirandeep; Sridharan, Vijayalakshmi et al. (2017) Space-type radiation induces multimodal responses in the mouse gut microbiome and metabolome. Microbiome 5:105

Showing the most recent 10 out of 997 publications