A new three-arm parallel design was recently proposed to investigate the biosimilarity between a biological product and a reference product by using the relative distance. The purpose of this article is to extend their results to binary endpoints for three popular metrics: the risk difference, the log relative risk, and the log odds ratio. The relative distances based on the three metrics are defined, and corresponding test procedures are developed. The type I error rates and powers are investigated theoretically and empirically.
All Science Journal Classification (ASJC) codes
- Statistics and Probability
- Pharmacology (medical)