This request for a competitive continuation grant of R13-CA132565 is to continue to facilitate advances in approaches to the statistical design, implementation and biostatistical analysis of clinical trials, through a continuing series of targeted symposia, involving both statisticians and clinicians. 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 continue to 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 methodological approaches in the context of the clinical, ethical and practical environments attendant to the problems being considered. The University of Pennsylvania has a flourishing Institute for Clinical and Translational Medicine and Therapeutics (ITMAT) and was awarded one of the first Clinical and Translational Science Awards (CTSA) which has solidified and formalized the long standing commitment of the Perelman School of Medicine at the University of Pennsylvania and its faculty and resources, to translational science, from early animal and clinical testing to post marketing surveillance of approved interventions. It is our intent to continue to incorporate into the proposed symposia a principle of the CTSA Program, to break down traditional research barriers to achieve efficient and ethical science. The objectives are to develop a series of clinical trials symposia, each focused on an area within one of the stages of assessment of an intervention;to bring together leading scientists (statisticians and clinicians) o 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;and to publish the proceedings of the symposia, including discussion, in a timely fashion in a peer reviewed journal. We strongly believe that the nature of clinical trials methodology is not disease specific although there will be a heavier use of certain methodologies in some areas of medicine Over a five-year continued grant period, our intent is to develop an additional five annual single day symposia. Our expectation is that meeting these objectives for the conference series will provide more than just a transfer of information, in allowing for an expansion of the available state-of-the-art information through the contrast of ideas and the elements of discussion. It is our belief that these focused discussions with experts and participants exchanging ideas should enhance the development of new statistical methodology for more efficient, cost effective and ethical evaluation of interventions.

Public Health Relevance

There is a continuing need for the development of scientifically sound, efficient, ethical, and safe methods for the assessment of human interventions. The competitive renewal of the existing conference grant (R13-CA132565) will fund the continuation of this highly successful conference series to continue to develop the needs and statistical approaches to address the complex paradigm of drug development for the benefit of public health.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Conference (R13)
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Special Emphasis Panel (ZCA1-PCRB-G (O1))
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Witherspoon, Kim
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University of Pennsylvania
Biostatistics & Other Math Sci
Schools of Medicine
United States
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