DESCRIPTION (provided by applicant):
This application supports the participation of the University of Chicago in Cancer and Leukemia Group B (CALGB) trials, including scientific and regulatory activities. The CALGB develops and performs clinical trials, primarily large scale clinical trials, to advance the treatment of cancer patients. The University of Chicago is a leading member of CALGB, supplying scientific and administrative leadership including the Group Chair (Dr Schilsky), Committee Chairs (Drs Ratain, Vokes, and Larson), and Study Chairs. Preliminary studies performed at the University of Chicago are taken to CALGB for large scale testing. Laboratories at the University of Chicago perform correlative studies that support CALGB trials. University of Chicago senior faculty mentor junior faculty and fellows in cooperative group participation, with large meeting attendance and eight CALGB Foundation grants awarded to University of Chicago fellows and junior faculty during the past granting period. In addition, The University of Chicago and its eight affiliate institutions are consistently among the top five accruers to CALGB studies with broad participation across all tumor types and substantial minority accrual.
PRINCIPAL INVESTIGATOR:
The Principal Investigator, Dr. Gini Fleming, is a medical oncologist who has been the PI at the University of Chicago since 1999. She has been active in CALGB since 1995 and served as the PI representative on the Executive Committee of CALBG from 2000-2003. She is Director of the Medical Oncology Breast Program and Gynecologic Oncology Program at the University of Chicago. She is co- Principal Investigator of the University of Chicago Breast Cancer SPORE. She is the United States Breast Intergroup Co-chair for the international CALGB-endorsed Suppression of Ovarian Function Trial in premenopausal women with non-metastatic breast cancer. She is very well qualified for her role.
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
Erollment of African-Americans at the University of Chicago has been maintained at approximately 26% and although this is higher than the proportion of African-Americans in the entire catchment area for the University of Chicago (15%), it is lower than both the proportion of African Americans using the medical center (62%) and the proportion of African Americans in the UCCRC Cancer Registry (29%). The enrollment of Hispanics is also low compared to national statistics for the percentage of cancer cases occurring in the Hispanic population. The University of Chicago has been a member of the the CALGB Minority Initiative program since 1993; however, plans to increase minority accrual are not well articulated in this grant. Although some steps to improve accrual have been identified, a clear, well articulated plan with significant potential for success is not given. Nonetheless, overall minority accrual is acceptable.
INCLUSION OF CHILDREN PLAN (Resume): ACCEPTABLE
Subjects older than age 18 are enrolled.
OVERALL RECOMMENDATION:
This application is rated excellent and is recommended for six years of support. |