New strategies for confirmatory testing of secondary hypotheses on combined data from multiple trials.
Marc VandemeulebroeckeDieter A HäringEva HuaXiaoling WeiDong XiPublished in: Clinical trials (London, England) (2024)
Inference on combined data across trials is a useful approach for generating pivotal evidence of efficacy for important but sample size-intense secondary endpoints. It requires careful preparation and regulatory discussion.