DESCRIPTION (provided by applicant): The overall objective of this project is to provide support for the performance of clinical studies of the Cancer and Leukemia Group B at the Lombardi Cancer Center at Georgetown University Medical School. The LCCCC/GUMC is an NCI-designated Comprehensive Cancer Center. Louis M. Weiner, M.D. was appointed Director of the Cancer Center on January 1, 2008. The CALGB Board of Directors approved LCCCC/GUMC as a main member institution in March, 1997. LCCCC/GUMC participates in the entire range of multimodality clinical studies including therapeutic studies, correlative science studies, and companion studies of quality of life, survivorship, and cost effectiveness analyses. LCCC faculty have been active in all three areas of CALGB activities: accrual, scientific leadership, and administrative tasks. At the present time 36 CALGB protocols are active at GUMC/LCCC. During the period from 2003-2007 622 patients have been entered onto CALGB or Intergroup trials. LCCCC/GUMC faculty are represented on 13 Committees. Three LCCCC/GUMC faculty members served as study chairs and three faculty members participated in CALGB audits. It is anticipated that LCCCC/GUMC investigators will continue their activities in the CALGB and new/young faculty members will become involved in the scientific endeavors of the group as they grow in their careers. LCCC/GUMC faculty members have been a co-author or primary author on 35 CALGB publications.
PRINCIPAL INVESTIGATOR:
Dr. Gelman served as PI from July, 2001, until his departure in February, 2007, after which Dr. Liu assumed the role of institutional PI. Dr. Liu has an interest in the translational aspects of breast cancer, which melds well with both the institutional and CALGB priorities in breast cancer clinical research. Dr. Liu is relatively junior for this role and may require additional divisional and institutional support to ensure CALGB priorities are adequately represented.
PROTECTION OF HUMAN SUBJECTS (Resume): ACCEPTABLE
Safeguards are adequate.
INCLUSION OF WOMEN PLAN (Resume): ACCEPTABLE
Accrual of women is acceptable.
INCLUSION OF MINORITIES PLAN (Resume): ACCEPTABLE
Minority accrual is acceptable.
INCLUSION OF CHILDREN PLAN (Resume): ACCEPTABLE
Subjects older than age 18 are enrolled.
OVERALL RECOMMENDATION:
This application is rated very good. |