title: Sample size determination in superiority clinical trials with multiple co-primary correlated endpoints.
abstract: In pharmaceutical drug development, for regulatory purposes, there are increasing discussions on the establishment of statistically significant results demonstrating the efficacy of a new treatment on multiple co-primary endpoints. At the design stage with multiple co-primary endpoints, it is critical to determine the appropriate sample size for indicating statistical significance for all co-primary endpoints with preserving the intended power set, since the type II error increases as the number of co-primary endpoints increases. We provide fundamental formulae for power and sample size calculation with multiple co-primary endpoints and illustrate the aspect of the provided methods through numerical tables and examples.
authors.affiliation: Department of Biostatistics, Kyoto University School of Public Health, Kyoto, Japan. sozu.takashi.4s@kyoto-u.ac.jp
authors.forename: Takashi
authors.initials: T
authors.lastname: Sozu
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Sugimoto
authors.forename: Toshimitsu
authors.initials: T
authors.lastname: Hamasaki
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination; D015233:Models, Statistical; D016011:Normal Distribution; D016017:Odds Ratio; D018401:Sample Size