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Sample size determination for clinical trials with co‐primary outcomes: exponential event times |
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| Authors: | Toshimitsu Hamasaki Tomoyuki Sugimoto Scott Evans Takashi Sozu |
| Affiliation: | 1. Department of Biomedical Statistics, Osaka University Graduate School of Medicine, , Japan;2. Department of Mathematical Sciences, Graduate School of Science and Technology, Hirosaki University, , Japan;3. Department of Biostatistics, Harvard School of Public Heath, , USA;4. Department of Biostatistics, Kyoto University School of Public Heath, , Japan |
| Abstract: | 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. Copyright © 2012 John Wiley & Sons, Ltd. |
| Keywords: | bivariate exponential distribution conjunctive power co‐primary endpoints copula log‐transformed hazard ratio right‐censored type II error rate |