Randomized controlled trials are the accepted standard for evaluating investigational therapies, but such trials are sometimes not an option for reasons of ethics or feasibility. Here, we discuss opportunities to address evidence gaps by using historical clinical trial data and real-world data in external control arms for single-arm trials, as well as the associated challenges.

中文翻译：

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通过外部控制通知单臂临床试验。

随机对照试验是评估研究性疗法的公认标准，但出于伦理或可行性的原因，此类试验有时不是一种选择。在这里，我们讨论了通过在单臂试验中使用历史临床试验数据和外部控制臂中的真实数据来解决证据差距的机会，以及相关的挑战。