A regulatory agency usually requires two independent positive trials of the same new drug for approval. If two different new drugs are approved with the -margin approach by using the same active control, it implies that four noninferiority trials share the same active control. Sharing the same active control generates dependencies among trials. In this paper we investigate how much such dependencies inflate the unconditional and conditional across-trial type I error rates, and we propose a new procedure to adjust the inflated unconditional across-trial type I error rates.
Bibliographical noteFunding Information:
This work was supported by grant R01-2007-000-20713-0 from the Basic Research Program of the Korea Science & Engineering Foundation.
All Science Journal Classification (ASJC) codes
- Statistics and Probability
- Pharmacology (medical)