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主题:【原创】在医学上什么是证据?送给无知的人们 -- 虽远必诛

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家园 FDA的规定也是这样,样本不多

Phase 0

Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15)

Phase I

Phase I trials are the first stage of testing in human subjects. Normally, a small (20-50) group of healthy volunteers will be selected.

Phase II

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works

Phase III

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied)

没找到FDA对Phase IV的规定样本数量,但在FDA网站上有个药的Phase IV Protocol文件上说是1500个样本数量。

当然,美国的FDA面对的人口基数低一些,只有3亿而已,呵呵。

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