- 程序有所改变。发帖如还有问题请报告
- 【征集】西西河的经济学，及清流措施，需要主动参与者，『稷下学宫』新认证方式，24年网站打算和努力目标
主题：【原创】在医学上什么是证据？送给无知的人们 -- 虽远必诛
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。
- 相关回复 上下关系8
压缩 5 层
🙂这个数字只是允许上市的标准， 发沙 字87 2009-12-20 07:36:11
🙂这个问题很好回答 肉包 字501 2009-12-20 05:59:49
😄要不说国内的临床没人认可呢 橡树村 字246 2009-12-19 08:58:34
🙂FDA的规定也是这样，样本不多
🙂面对的人口是60亿 橡树村 字136 2009-12-19 09:46:00
🙂已发了统计学求解贴了，村长有兴趣吗？ meokey 字166 2009-12-19 10:00:47
😨我的统计学忘得差不多了 橡树村 字269 2009-12-19 10:03:15
🙂我的感觉是国内的医生只比较注重是否过敏。 发沙 字50 2009-12-19 07:52:30