3 OVERALL REVIEW CRITERIA AND IMPACT 3 FUNDING OPPORTUNITY ANNOUNCEMENT (FOA) SPECIFIC CRITERIA 10 ORGANIZATION AND STRUCTURE 10 CLINICAL TRIALS RESEARCH PROGRAM 12 CANCER CARE DELIVERY RESEARCH PROGRAM 13 OPERATIONS/DATA MANAGEMENT 15 PROTECTIONS FOR HUMAN SUBJECTS 17 INCLUSION OF WOMEN, MINORITIES, AND CHILDREN 17 RESOURCE SHARING PLAN 17 BUDGET AND PERIOD OF SUPPORT 17 SPECIAL EMPHASIS PANEL ROSTER DESCRIPTION (provided by applicant): The Gulf South-Minority Based-NCI Community Oncology Research Program (GS-MB-NCORP) brings together an integrated clinical trials program from two Minority Based CCOPs (MBCCOP) and an NCCCP site in the state of Louisiana, supported by well-established and funded Cancer Care Delivery Research and programs in Health Disparities and Community-Based Participatory Research. The MBCCOP established by the LSU School of Medicine in New Orleans (LSUHSC-NO-MBCCOP) and its NCCCP partner, the Mary Bird Perkins Cancer Center - Our Lady of the Lake Hospital (MBP-OLOL) in Baton Rouge, have joined the MBCCOP at the LSU School of Medicine in Shreveport (LSUHSC-SH-MBCCOP) in northwest Louisiana to create the GS-MB-NCORP. This consortium integrates well-established and experienced teams of clinicians and researchers with the aim of expanding access to state-of-the-art cancer clinical trials to the patients we serve, through a network of leading academic and community hospitals. Louisiana has one of the poorest survival rates for cancer patients in the United States, despite not having the highest incidence for all types of the disease. This is particularly true for underserved and minority patients, clealy reflecting a major health disparity. Possible explanations for this disparity range from socio-economic and access to health care, to poorly understood genetic and biological differences. The LSU MBCCOPs and the NCCCP at MBP-OLOL have independently worked to increase access to clinical trials for minority and underserved communities, establish outreach and education programs, and expand Cancer Care Delivery Research and Health Disparity studies. In the fall of 2012, we agreed to combine our strengths and experience into the GS-MB-NCORP with the goal of having a more significant impact on cancer associated health disparities by integrating our clinical trials programs and incorporating Cancer Care Delivery and Health Disparity researchers into the clinical trials process. The GS-MB-NCORP's goals are to increase the participation of minorities and underserved populations in clinical trials, identify barriers t participation, and incorporate the community in the research studies. To achieve this, we propose the following Specific Aims. 1) Advance an integrated system of access to cancer clinical trials that promote and facilitate the participation and enrollment of patients, in particlar underserved and minority populations in Louisiana. 2) Promote Cancer Care Delivery Research Programs to ensure our ability to participate in research initiatives proposed by the Research Bases, and eventually design protocols that improve the care of our patients. 3) Expand Health Disparities Research programs through community engagement to increase the participation of minority and underserved populations in clinical trials
The GS-MB-NCORP will contribute significantly to the agenda o fthe National Cancer Institute and the Research Bases, by increasing access to prevention, early detection and cutting edge clinical trials to minority and underserved patients in Louisiana. It will further enhance the biomedical and clinical workforce in our state by increasing the number of professionals experienced in conducting health disparities research, developing cancer care delivery capabilities and implementing advanced clinical trials.