During the past decade, various sequential design methods in clinical trial designs have been developed to allow for interim decisions and trial modifications based on cumulated information. As part of well-known adaptive designs in group sequential analysis, Yu Shen and Lloyd Fisher proposed a sequential strategy for monitoring clinical trials, namely self-designing trials. The final test statistic is a weighted average of the sufficient statistic from each stage, where the weight for each stage is determined by the observed data prior to that stage. One important feature of this self-designing trial is that the maximum sample size or the maximum number of interim analyses, m, is not specified in advance but at a random stopping time. The flexibility of modifying the sample size allows ...

  • Loading...
locked icon

Sign in to access this content

Get a 30 day FREE TRIAL

  • Watch videos from a variety of sources bringing classroom topics to life
  • Read modern, diverse business cases
  • Explore hundreds of books and reference titles