DESCRIPTION (provided by applicant): Roswell Park Cancer Institute (RPCI) is requesting support to continue its participation in the Cancer and Leukemia Group B (CALGB). The goals of our participation in CALGB include the following: (1) to continue our strong contribution to the scientific agenda of the Group, (2) to continue our performance of pilot activity at the local level that can be considered for Group adaptation, (3) to continue our administrative support for the efficient functioning of the Group, (4) to sustain accrual in order to allow the rapid accumulation of clinical data and experience through the cooperative group process, and (5) to continue to provide data of high quality in a timely manner. Over the last grant period, we have contributed substantially to the scientific, administrative, core, and publication activities of the CALGB. More specifically, 6 RPCI members serve or have served as chairs or vice chairs of scientific committees; 16 serve or have served as members on scientific committees; 12 serve or have served as study chairs or vice-chairs on 22 protocols; 3 have protocols under consideration; 9 provide or have provided core services to the Group; and 5 have performed pilot studies that have led to the development of CALGB protocols. RPCI members have contributed to 71 publications and given 58 education sessions. Furthermore, 8 members have or have had administrative roles in the Group. RPCI also represents an ongoing resource of ideas for future CALGB science; RPCI has a vigorous Phase I/II program with many protocols potentially exportable to the Group. CALGB accrual by RPCI is customarily between 200-250 credits/year. Data quality and timeliness of submission has met Group standards. The campus spans 25 acres in downtown Buffalo and consists of 10 research and clinical buildings with approximately one million square feet of space. Statistics for fiscal year 2006-2007 include 6805 new cancer cases, 4215 hospital admissions, and 161,869 outpatient visits from patients in 36 states and 5 foreign countries. Both the inpatient and the outpatient centers are located in a spacious facility that opened in 1998.
PRINCIPAL INVESTIGATOR:
Dr. Ellis Levine is Principal Investigator for the CALGB RPCI application. He has served in this capacity for the last 14 years. He is an Associate Professor of Medicine at the State University of New York at Buffalo, NY. He has a track record of accomplishments and publications; his extramural support has been primarily as through the U10 grant. He is qualified for his role on this application.
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. Minority recruitment to treatment studies is approximately 11% which is in line with the proportion of minorities in the catchment population over the age >55. RPCI has taken measures to expand the minority outreach which likely will result in enhanced minority recruitment to clinical trials in the future.
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. |