只有臨床試驗充分反映最有可能使用藥物的人群，才能獲得藥物上市后用藥人群不同亞群的臨床安全有效使用的準確信息。然而目前許多臨床試驗的某些人群的代表性仍然不足。為改變這種狀態(tài)，美國食品藥品監(jiān)督管理局（FDA）于2020年11月發(fā)布了“提高臨床試驗人群的多樣性——合格標準、納入實踐和試驗設(shè)計供企業(yè)用指導原則”。該指導原則推薦了許多方法，擴大臨床試驗參與者的合格標準、避免不必要地排除，促進臨床試驗人群的多樣性，內(nèi)容豐富、詳實、切實可行。詳細介紹該指導原則，期待對我國積極開展這方面的工作有促進作用。

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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