Optimal sample size determinations from an industry perspective based on the expected value of information

BACKGROUND: Traditional sample size calculations for randomized clinical trials depend on somewhat arbitrarily chosen factors, such as type I and II errors. As an alternative, taking a societal perspective, and using the expected value of information based on Bayesian decision theory, a number of authors have recently shown how to determine the sample size that maximizes the expected net gain, i.e., the difference between the cost of the trial …