This application describes the manner in which investigators at the Pittsburgh Cancer Institute (PCI) have organized a clinical trials system which will develop with PCI's CCOP collaborators innovative trials in cancer therapy and cancer prevention and control. Principal investigator for this CCOP Research Base is Dr. Donald L Trump. He is assisted by Drs Lembersky and Weissfeld who possess unique expertise in the development of cancer therapy and control trials, respectively. The expertise of investigators at PCI for development of cancer therapy and control trials is outstanding. In addition, the recent experience of Dr. Ronald Herberman, PCI Director, and Dr. Trump who were asked to serve as interim chair and executive officer, respectively, for the National Surgical Adjuvant Breast and Bowel Project provides extraordinary experience in the organization and conduct of multi-institutional clinical trials. Biostatistical, data management and quality assurance procedures at PCI together with the experience of this team of investigators will provide excellent leadership for the development of an outstanding CCOP Research Base. The PCI CCOP Research Base will develop therapy and cancer prevention and control trials. This application describes the manner in which CCOP investigators will be integrated into the clinical and administrative operations of the PCI CCOP Research Base structure in order to assure the development of high quality protocols which address important questions in cancer therapy and control for PCI CCOP and Minority-based CCOP affiliates. Letters of commitment to consider naming PCI as a CCOP Research Base have been received from eight CCOPs.
