Many-to-one comparison after sample size reestimation for trials with multiple treatment arms and treatment selection.
Sample size reestimation (SSRE) provides a useful tool to change the sample size when an interim look reveals that the original sample size is inadequate. To control the overall type I error, for testing one hypothesis, several approaches have been proposed to construct a statistic so that its distribution is independent to the SSRE under the null hypothesis. We considered a similar approach for comparisons between multiple treatment arms and placebo, allowing the change of sample sizes in all arms depending on interim information. A construction of statistics similar to that for a single hypothesis test is proposed. When the changes of sample sizes in different arms are proportional, we show that one-step and stepwise Dunnett tests can be used directly on statistics constructed in the proposed way. The approach can also be applied to clinical trials with SSRE and treatment selection at interim. The proposed approach is evaluated with simulations under different situations.
Wang
Jixian
J
Novartis Pharma AG, Basel, Switzerland. jixian.wang@novartis.com
D000465:Algorithms; D015982:Bias; D056808:Biostatistics / Q000379:methods*; D003198:Computer Simulation; D018849:Controlled Clinical Trials as Topic / Q000379:methods*; D015340:Epidemiologic Research Design; D006801:Humans; D012107:Research Design; D018401:Sample Size; D016896:Treatment Outcome