Sample size determination for clinical trials with co-primary outcomes: exponential event times.
Clinical trials with event-time outcomes as co-primary contrasts are common in many areas such as infectious disease, oncology, and cardiovascular disease. We discuss methods for calculating the sample size for randomized superiority clinical trials with two correlated time-to-event outcomes as co-primary contrasts when the time-to-event outcomes are exponentially distributed. The approach is simple and easily applied in practice.
Department of Biomedical Statistics, Osaka University Graduate School of Medicine, Osaka, Japan. hamasakt@medstat.med.osaka-u.ac.jp
Toshimitsu
T
Hamasaki
Tomoyuki
T
Sugimoto
Scott
S
Evans
Takashi
T
Sozu
D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D006801:Humans; D015233:Models, Statistical; D009010:Monte Carlo Method; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome