Innovative Clinical Trial Designs That Control For Multiplicity
*Walter W Offen, AbbVie 

Keywords: innovative, design, multiplicity

In recent years there have been many discussions at scientific meetings and in the literature regarding innovative clinical trial designs, including adaptive designs and gatekeeping strategies. Many of these present challenges in controlling the Type I error rate. This talk will provide an overview of important designs and related approaches for multiplicity adjustment that improve statistical power. In the event that the FDA Multiplicity Draft Guidance is released prior to this meeting, we will also highlight the content which has the greatest impact on industry-sponsored clinical trials, and will provide commentary regarding the corresponding approaches proposed in that guidance.