Abstract
Background: In this article, we study the sample size calculations for the combination drugs of 2 monotherapies with a single approved dose level when the primary endpoints are binary. Methods: Two study cases are examined: In the first, each monotherapy has the same indication, while in the second, each monotherapy has a different indication. The sample sizes are calculated by using an asymptotic joint distribution of test statistics and employing unequal allocation for 3 popular measures of 2 proportions: the risk difference, the log relative risk, and the log odds ratio. Results: Results show that our proposed method produces smaller total sample sizes compared with the heuristic method. Conclusions: The total sample sizes can be reduced by incorporating unequal allocation and dependency between 2 test statistics.
| Original language | English |
|---|---|
| Pages (from-to) | 181-189 |
| Number of pages | 9 |
| Journal | Therapeutic Innovation and Regulatory Science |
| Volume | 51 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 2017 Mar |
Bibliographical note
Funding Information:This research was supported by the Basic Science Research Program through the National Research Foundation of Korea (NRF), funded by the Ministry of Education, Science and Technology (2013R1A1A2004920).
Publisher Copyright:
© The Author(s) 2016.
All Science Journal Classification (ASJC) codes
- Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
- Public Health, Environmental and Occupational Health
- Pharmacology (medical)
