Assessing accuracy of Weibull shape parameter estimate from historical studies for subsequent sample size calculation in clinical trials with time-to-event outcome

摘要

Recent developments in literature on sample size calculations for time-to-event outcomes involve assumption of Weibull distributed times. These methods require a point estimate of the Weibull shape parameter obtained from historical studies. However, very limited guidance exists in published literature to assess how reliable this point estimate is when it is obtained from published results of a historical study.