美國食品藥品監(jiān)督管理局（FDA）于2023年11月發(fā)布了"糖尿病足感染：開發(fā)治療藥物的供企業(yè)用的指導(dǎo)原則（草案）"。該指導(dǎo)原則草案提出了糖尿病足感染治療藥物臨床開發(fā)的建議，包括對這類藥物臨床試驗(yàn)設(shè)計(jì)關(guān)鍵要素的許多具體建議，如試驗(yàn)設(shè)計(jì)、試驗(yàn)人群、療效評估等方面。而我國目前尚沒有類似的指導(dǎo)原則。詳細(xì)介紹FDA該指導(dǎo)原則草案，期望對我國這類藥物開發(fā)的臨床研究及其評價(jià)有所裨益。

The U.S. Food and Drug Administration (FDA) issued the "Diabetic Foot Infections:Developing Drugs for Treatment Guidance for Industry (Draft)" in November 2023. This draft guidance offers recommendations for the clinical development of therapeutic drugs for diabetic foot infections, including numerous specific suggestions for key elements in the clinical trials of such drugs, such as trial design, trial population, efficacy evaluation, etc. Currently, there is no similar guidance available in China. This article provides a detailed introduction to the FDA's draft guidance, with the hope of benefiting the clinical research and evaluation of drug development of this type in China.

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