There is a continuing need for the development of scientifically sound, efficient, ethical, and safe methods for the assessment of human interventions. The motivation for this proposal is to facilitate advances in approaches to the statistical design, implementation and biostatistical analysis of clinical trials, through a continuing series of targeted symposia. Each symposium will focus entirely on an area approximately within commonly accepted definitions of stages in the development of an intervention (animal and laboratory studies, early human and dose finding studies, early efficacy and transition studies, definitive efficacy studies, post marketing studies). The topic for each symposium will be chosen annually, based on the suitability of an area to benefit from a concentrated symposium, and its potential impact on the practice of clinical trials. We expect that the symposia will address problems and produce solutions that translate readily across disease areas, which historically has been the case for biostatistical methodology, regardless of the disease area that inspired its development. Every symposium is expected to examine statistical methodological approaches in the context of the clinical, ethical and practical environments attendant to the problems being considered. The structural model for the conference roughly involves getting the cogent thinkers of the day in a particular area together to make formal presentations, create an environment for active discussion, and importantly, provide rapid publication (goal, one year from conference). Our specific objectives are to: develop a series of clinical trials symposia, each focused on an area within one of the five stages of assessment of an intervention;bring together leading scientists to be involved in the presentation and discussion of the state of the art and expected developments in these areas;to have pre-conference review by organizers in order to establish controversy and equipoise in the targeted area and incorporate such into program;to seek an audience with both expertise and commitment to participate in the symposia;to publish the proceedings of the symposia, including discussion, as quickly as possible in a peer reviewed journal. Our expectation is that meeting these objectives for the conference series will provide more than just a transfer of information, allowing for an expansion of the available state-of-the-art information through the contrast of ideas and the elements of discussion.
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