Design of Insomnia Drug Trials and Related Statistical Issues
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*Kun Jin, FDA 


The design of insomnia drug trials is usually difficult in terms of statistical analyses. The trial for insomnia indication is more complicated due to the multiple endpoints for latency or maintenance claims, early and late time points for efficacy evaluation, objective and subjective measurements and multiple doses. In this talk, some new requirements for the insomnia indication will be discussed. These new requirements may significantly reduce the burden of the design of statistical decision rule and related analysis methods.