只有临床试验充分反映最有可能使用药物的人群，才能获得药物上市后用药人群不同亚群的临床安全有效使用的准确信息。然而目前许多临床试验的某些人群的代表性仍然不足。为改变这种状态，美国食品药品监督管理局（FDA）于2020年11月发布了“提高临床试验人群的多样性——合格标准、纳入实践和试验设计供企业用指导原则”。该指导原则推荐了许多方法，扩大临床试验参与者的合格标准、避免不必要地排除，促进临床试验人群的多样性，内容丰富、详实、切实可行。详细介绍该指导原则，期待对我国积极开展这方面的工作有促进作用。

Only when clinical trials fully reflect the populations most likely to use drugs, can we obtain accurate information about the clinical safe and effective use of drugs in different subgroups of drug users after marketing. However, certain groups continue to be underrepresented in many clinical trials at present. In order to change this situation, FDA issued Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry in November 2020. The Guidance recommend many methods to expand the eligibility criteria of clinical trial participants, avoid unnecessary exclusion, and promote the diversity of clinical trial populations. The content is extremely rich, detailed and practical. However. This paper introduces the guidance in detail, hoping to promote the work in this area in China.

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