Optimal clinical trial design using value of information methods with imperfect implementation

Traditional sample size calculations for randomized clinical trials are based on the tests of hypotheses and depend on somewhat arbitrarily chosen factors, such as type I and II errors rates and the smallest clinically important difference. In response to this, many authors have proposed the use of methods based on the value of information as an alternative. Previous attempts have assumed perfect implementation, i.e. if current evidence favors …