Overestimation of the Effect Size in Group Sequential Trials
Overestimation of the Effect Size in Group Sequential Trials
Group sequential designs (GSD), which provide for interim monitoring of efficacy data and allow potential early trial termination while preserving the type I error rate, have become commonplace in oncology clinical trials. Although ethically appealing, GSDs tend to overestimate the true treatment effect size at early interim analyses. Overestimation of …