The University of Michigan Comprehensive Cancer Center (UMCCC), a matrix organized, NCI Core Grant supported Comprehensive Cancer Center, proposes to establish a new CCOP Research Base focused solely on Cancer Prevention and Control. The rationale for a CCOP Research Base at the UMCCC rests upon the recent evolution of a strong, competitive translational scientific infrastructure devoted to Cancer Prevention and Control at the UMCCC associated with the recognition that Cancer Prevention and Control Research is likely to be most successful when focused in the community.
The specific aims of this proposal are to I) Create an organizational infrastructure within the UMCCC to support a CCOP Research Base; 2) Establish a highly interactive, collaborative Mid-West Cancer Prevention and Control Consortium consisting of five CCOPs in Michigan and Ohio within a four hour drive of Ann Arbor that is responsive to the priorities of the Cancer Prevention and Control program of the National Cancer Institute; 3) Implement a high-quality, Internet Based document and data management system; 4) Develop, activate and enroll subjects to Cancer Prevention and Control Protocols led by translational science investigators from the Cancer Prevention and Control Division of the UMCCC and other collaborating Institutions focused upon Chemoprevention; Nursing Oncology; Behavior Modification and Population Education; Molecular Epidemiology and Recruitment and Retention of Underrepresented Minority Populations in Clinical Research; and 5) Establish links between each affiliated CCOP and Primary Care physicians. To meet these specific aims, the UMCCC CCOP Research Base has established the technical support to handle data meeting current Good Clinical Practice and NCI guidelines. These include internal data quality control methods, auditing procedures, database management methods, ADR reporting procedures, protections of human subjects, and performance guidelines for CCOPs. Governance of the CCOP will consist of a CCOP Research Base Executive Committee and a PI Review Committee consisting of CCOP PIs. All concepts and protocols must be approved by both Committees prior to NCI CCPRC Review. Research protocols will focus upon Phase I and II prevention tasks and will be structured to provide the necessary preliminary data to merit consideration for larger trials requiring the resources of National Cooperative Groups.
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