OPERATIONS CENTER FOR AIDS-ASSOCIATED MALIGNANCIES

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DESCRIPTION: (Applicant's Description) This proposal is for the Comprehensive Cancer Center Biostatistics Unit at the University of Alabama at Birmingham (UAB) to serve as the Operations, Statistical and Data Management Center (OMC) for the AIDS-Associated Malignancies Clinical Trials Consortium. The purpose of the Consortium is to design and conduct clinical trials with novel agents or innovative approaches in patients with AIDS-associated malignancies, primarily Non-Hodgkin's Lymphoma (NHL), Kaposi's sarcoma (KS), Hodgkin's disease, anogenital dysplasia, anal and cervical cancer. It is anticipated that the Consortium will perform four to six clinical trials and enroll 200 patients per year with AIDS-associated malignancies from 8 to 10 clinical centers. The OMC will centralize many activities of the clinical trials, and will serve as the communications hub for the Consortium. The OMC will provide statistical expertise to the Consortium in the areas of study design, sample size, and analyses; coordinate the development, submission, conduct and analysis of protocols undertaken by the Consortium; establish and implement quality control procedures; monitor the conduct of the clinical trials; establish and implement procedures for data management; maintain the database for the clinical trials; perform all statistical analyses; manage the Discretionary Fund; coordinate the acquisition and shipping of specimens and relevant clinical data to the Tissue and Biological Fluids Banks of HIV- Associated Malignancies; and provide administrative support for the study. The Biostatistics Unit has considerable experience in serving as the statistical coordinating center for multicenter clinical trials groups. The location of all personnel involved in coordinating center activities in one physical location is both cost and time efficient. With both an NIH-funded Comprehensive Cancer Center and Center for AIDS Research at UAB, expertise in the medical, virologic, oncologic, immunologic, epidemiologic, and behavioral areas will be available to the OMC on an ongoing basis.