The overall purpose of the Clinical Studies Core is to support clinical investigations of this Project. We are requesting that Clinical Core funding be started in year two since most of the studies will not be initiated until year two.
Specific Aims are: a) To provide for optimal support and environment to undertake clinical research for investigators in the project. b) To provide patients and referring physicians access to clinical research treatments, development by investigators of this project. c) To enhance productive interactions of investigators of this project. d) To coordinate and enhance use of resource available for the support of clinical investigations at UAB (outlined below) by investigators of this project. The Core will be directed by Dr. John Rinehart who will provide overall leadership and administration of the Core and coordination among its 8 Components: 1) the UAB-NCI Comprehensive Cancer Center, 2) a Clinical Studies Unit which provides complete support for over 150 clinical trials, 3) the UAB-CCC Community Breast Cancer Network, recently funded by the DOD to enhance patient and referring physician access to translational breast cancer clinical trials, 4) a Clinical Trials Review Committee which provides critical review and prioritization of clinical cancer investigations, 5) Biostatistics Shared Facility, which provides expertise in planning and analysis of clinical trials, 6) the Breast Cancer Committee which provides for comprehensive disease specific review of clinical research projects, 7) the Pittman General Clinical Research Center (GCRC), which provides for care and management of patients on clinical trials on an outpatient or inpatient basis, 8) the Comprehensive Cancer Center Recruitment & Retention Shared Facility (RRSF) which provides a range of strategies to enhance patient access to clinical trials A Clinical Studies Core Committee, composed of the Directors of the eight components of the Core, will meet monthly to review clinical protocols under development with the protocol coordinator-principal investigator (PI) for the purpose of planning a strategy to ensure expeditious activation and completion of the project by optimally utilizing the resources of the Clinical Studies Core components.
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