Regulatory Perspectives: Adaptive Design Trial Conduct
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*Renee C Rees, FDA/CBER 

Keywords: Adaptive design, FDA guidance, study conduct

Recent high-profile events have increased interest in the conduct of clinical trials including: the February 2010 release of the FDA guidance Adaptive Design Clinical Trials and the October 2010 retraction of the Journal of Clinical Oncology 2007 genomics article by Nevins et al from Duke University due to data management issues. Study conduct in all types of clinical trials can derail scientific research and lead to questionable data of limited value for analysis. This session will focus on points-to-consider when planning and conducting adaptive design trials not only from an analysis perspective, but also taking into account planning for more complex randomizations, enrollment, blinding issues, clinical supplies, data management, results dissemination and FDA guidance. Specific attention will be paid to who and when access is granted to trial data for adaptations to the design.