临床试验法规的意外后果。
The unintended consequences of clinical trials regulations.
机构信息
Dental School, Faculty of Medicine, University of Glasgow, Glasgow, Scotland.
出版信息
PLoS Med. 2009 Nov;3(11):e1000131. doi: 10.1371/journal.pmed.1000131. Epub 2009 Nov 17.
Abstract
Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.
摘要
亚历克斯·麦克马洪（Alex McMahon）及其同事对国际协调会议（ICH）关于良好临床规范（GCP）的指导意见提出批评，认为该指导意见正在对欧洲的非商业性随机临床试验产生灾难性影响。
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