Optimal clinical trial design using value of information methods with imperfect implementation
提出一个框架，在临床试验设计中放松完美实施假设，用价值信息方法优化样本量，并评估实施策略的价值，通过两个实例展示其对最优样本量和预期净收益的显著影响。
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 the new intervention and no new information is sought or expected, all future patients will receive it. A framework is proposed to allow for this assumption to be relaxed. The profound effect that this can have on the optimal sample size and expected net gain is illustrated on two recent examples. In addition, a model for assessing the value of implementation strategies is proposed and illustrated.