Hauck W W, Preston P E, Bois F Y
Biostatistics Section, Division of Clinical Pharmacology, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA.
J Biopharm Stat. 1997 Mar;7(1):87-96. doi: 10.1080/10543409708835171.
Group sequential methods to allow the possibility of early termination of a trial due to sufficiently convincing results are a standard in therapeutic clinical trials but have been little considered in bioequivalence trials. We investigate the statistical properties of one group sequential approach to bioequivalence trials. In particular, we are interested in maintenance of level (5%), quantification of any loss of power, and the probability of early stopping. These properties are assessed via data simulated according to a pharmacokinetic model. We find that there are cases where a group sequential approach has a substantial probability of early stopping, with essentially no loss of power.
成组序贯方法允许由于结果足够有说服力而提前终止试验，这在治疗性临床试验中是标准做法，但在生物等效性试验中却很少被考虑。我们研究了一种用于生物等效性试验的成组序贯方法的统计特性。特别地，我们关注检验水准（5%）的维持、效能损失的量化以及提前停止的概率。这些特性通过根据药代动力学模型模拟的数据进行评估。我们发现，在某些情况下，成组序贯方法有很大的提前停止概率，且效能基本没有损失。
