Futility Rules in Bioequivalence Trials with Sequential Designs

Group sequential designs for clinical trials.

Futility stopping in clinical trials

Early stopping due to futility, also referred to as a go/nogo decision, during interim analysis has become an important feature of clinical trial designs. Current methods for futility stopping in literature are mostly based on conditional power or predictive power in conjunction with the theory of stochastic curtailment or group sequential design. They have certain drawbacks that have been note...

Choice of futility boundaries for group sequential designs with two endpoints

BACKGROUND In clinical trials, the opportunity for an early stop during an interim analysis (either for efficacy or for futility) may relevantly save time and financial resources. This is especially important, if the planning assumptions required for power calculation are based on a low level of evidence. For example, when including two primary endpoints in the confirmatory analysis, the power ...

Additional results for 'Sequential design approaches for bioequivalence studies with crossover designs'.

In 2008, this group published a paper on approaches for two-stage crossover bioequivalence (BE) studies that allowed for the reestimation of the second-stage sample size based on the variance estimated from the first-stage results. The sequential methods considered used an assumed GMR of 0.95 as part of the method for determining power and sample size. This note adds results for an assumed GMR ...

Determination of sample size for two stage sequential designs in bioequivalence studies under 2x2 crossover design

Sequential design is an adaptive design that allows for pre-mature termination of a trial due to efficacy or futility based on the interim analyses. The concept of sequential statistical methods was originally motivated by the need to obtain clinical benefits under certain economic constraints. That is for a trial for a positive results, early stopping ensures that a new drug product can exploi...