只有臨床試驗(yàn)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(zhǔn)確信息。然而目前許多臨床試驗(yàn)的某些人群的代表性仍然不足。為改變這種狀態(tài)，美國(guó)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(yàn)人群的多樣性——合格標(biāo)準(zhǔn)、納入實(shí)踐和試驗(yàn)設(shè)計(jì)供企業(yè)用指導(dǎo)原則”。該指導(dǎo)原則推薦了許多方法，擴(kuò)大臨床試驗(yàn)參與者的合格標(biāo)準(zhǔn)、避免不必要地排除，促進(jìn)臨床試驗(yàn)人群的多樣性，內(nèi)容豐富、詳實(shí)、切實(shí)可行。詳細(xì)介紹該指導(dǎo)原則，期待對(duì)我國(guó)積極開展這方面的工作有促進(jìn)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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