Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine. In this series in Fertility and Sterility, several aspects of RCTs are discussed, with contributions on multicenter RCTs, different international settings, and integrity of RCTs. The present contribution deals with methodologic issues. We discuss different types of RCTs based on null hypothesis (superiority vs. noninferiority vs. equivalence) as well as frequentist versus Bayesian interpretation. We also discuss the use of RCTs in the era of personalized medicine and RCTs to address diagnostic and prognostic questions. Finally, we address the use of big data compared with the use of RCTs.

中文翻译：

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生殖医学随机临床试验中的方法学考虑

随机对照试验 (RCT) 是循证医学的基石。在生育与不育系列中，讨论了 RCT 的几个方面，并对多中心 RCT、不同的国际环境和 RCT 的完整性做出了贡献。目前的贡献涉及方法论问题。我们讨论了基于零假设（优越性与非劣效性与等效性）以及频率论与贝叶斯解释的不同类型的 RCT。我们还讨论了在个性化医疗和 RCT 时代使用 RCT 解决诊断和预后问题。最后，我们将大数据的使用与 RCT 的使用进行比较。