Abstract
p-values are widely used to assess scientific evidence in randomized clinical trials despite the controversy surrounding its appropriate use and interpretation. A p-value is uniformly distributed under the null hypothesis while a distribution of a p-value under the alternative hypothesis is a function of sample size and posited alternative value in cases where the normal approximation can be assumed. This gives a sense of how sample sizes and posited alternative values affect the distribution of the p-value under the alternative hypothesis and it helps to plan a more plausible study based on its aims during the design stage. In this article, we investigate the distribution of a p-value under the alternative hypothesis when the outcome is binary, focusing on the exact approach where the normal approximation is not applicable due to a small sample size. The characteristics of a p-value distribution under the alternative hypothesis were illustrated in various scenarios. Our investigation of the distribution showed a p-value at an alternative value can be useful, especially when there is not much information during the planning stage due to a lack of preliminary findings.
| Original language | English |
|---|---|
| Pages (from-to) | 567-575 |
| Number of pages | 9 |
| Journal | Statistics in Biopharmaceutical Research |
| Volume | 17 |
| Issue number | 4 |
| DOIs | |
| State | Published - 2025 |
| Externally published | Yes |
Keywords
- Barnard’s exact CSM test
- Binary outcome
- Effect size
- Fisher’s exact test
- Power
- p-value
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