Abstract
We study matched pair designs with two binary endpoints under three different approaches. Power approximation and sample size calculation are derived under these situations and facilitated by R programs. An adaptive design with sample size re-estimation is also presented. Through extensive simulations, we provide general guidelines for practitioners to choose the best approach according to the ranges of the interested parameters in the sense of feasibility and robustness. Application to a cancer chemotherapy trial is illustrated.
| Original language | English |
|---|---|
| Pages (from-to) | 2526-2542 |
| Number of pages | 17 |
| Journal | Statistical Methods in Medical Research |
| Volume | 26 |
| Issue number | 6 |
| DOIs | |
| State | Published - 1 Dec 2017 |
Keywords
- Binary endpoint
- equivalence
- matched pair design
- non-inferiority