The Behavior of the P-value when the Alternative Hypothesis is True

The P-value is a random variable derived from the distribution of the test statistic used to analyze a data set and to test a null hypothesis. Under the null hypothesis, the P-value based on a continuous test statistic has a uniform distribution over the interval [0, 1], regardless of the sample size of the experiment. In contrast, the distribution of the P-value under the alternative hypothesis is a function of both sample size and the true value or range of true values of the tested parameter. The characteristics, such as mean and percentiles, of the P-value distribution can give valuable insight into how the P-value behaves for a variety of parameter values and sample sizes. Potential applications of the P-value distribution under the alternative hypothesis to the design, analysis, and interpretation of results of clinical trials are considered.