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Abstract:
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Any clinical trial should address an important research question, using rigorous methodology to answer the primary question of interest. Due to resource or size limitations, meeting these requirements present unique challenges when planning and designing small clinical trials. This presentation will review some specific designs that are useful in the small clinical trial context, specifically the use of more novel methods such as the futility design and adaptive designs. Statistical methods appropriate for these designs will be discussed. I will also discuss specific examples of trials initiated using these types of designs.
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