Two-stage designs with small sample sizes
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2022.2080691
Abstract: ABSTRACT When applying group-sequential designs in clinical trials with normally distributed outcomes, approximate critical values are often applied. Here, normally distributed test statistics are assumed which, however, are in fact t-distributed. For small sample sizes,… read more here.
Keywords: small sample; two stage; stage designs; sample sizes ... See more keywords
Optimal single-arm two-stage designs with consideration of dependency on efficacy and safety
Sign Up to like & getrecommendations! Published in 2022 at "Statistical Methods in Medical Research"
DOI: 10.1177/09622802221111553
Abstract: In phase II clinical trials on cancer, it is of great interest to establish the efficacy and safety of a new treatment simultaneously. Existing hypotheses may not achieve this goal effectively. We introduce two new… read more here.
Keywords: efficacy safety; two stage; stage designs;