Conference Program

Some Industry Trials Over the Last 30 Years and Associated Challenges (304753)

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*Keaven M. Anderson, Merck & Co., Inc. 

Keywords: group sequential design, multiplicity, clinical trials, software, methodology, history

We consider several industry group sequential trials and associated issues over the last 30 years. Generally, group sequential design has provided a great deal of flexibility to overcome many challenges in a relatively straightforward way compared to more complex adaptive designs. Among the issues considered are timing of and boundaries for interim and final analyses, dealing with multiple hypotheses created by dose groups, populations and endpoints, and statistical information. Tools for design and execution will also be discussed.