Abstract:
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Adaptive designs have gained in popularity since the first seminal paper by Bauer and Kohne 1994. Compared to the conventional designs, adaptive designs save patients and costs in exchange of the operational complexities. Statistical methodologies for performing appropriate final analysis in face of various adaptations including sample size re-esitmation, adaptive treatment selection and population enrichment has been addressed in the literature. Regulatory agencies in the United States and Europe have issued guidance documents for use of adaptive design in clinical trials.Two surveys have been conducted by the DIA Adaptive Design Working Group (Quinlan et al, 2010; Morgan et al,2014) to capture what is happening in reality. With the continuous efforts, this survey is to identify the improvements and consistent barriers with adaptive designs since the last survey.This survey consists of three parts:survey of use of adaptive design in real world, literature review and registry review.This presentation will touch upon the approach to the registry review,the main results of the registry review and the general trend over the four periods 2000-2003, 2004-2007, 2008-2011, and 2012-2015.
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