临床研究:clinical study
临床试验:clinical trial
就临床研究与临床试验而言,在书面的使用上其实区分并不明显,在英文中常是混用的。比如ICH的GCP(E6)中,就使用:Clinical Trial/Study 这样的形式来表述一个概念,并且在最后还特别注明了:"The terms clinical trial and clinical study are synonymous. "[1]。
从设计角度,trial属于有干预(interventions)的,而study可以没有干预,即study包含了观察性研究。从这个意义上讲,trial不等于study。
ClinicalTrials.gov 上面有句话,说的比较清楚了:
There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. ClinicalTrials.gov includes both interventional and observational studies.[2]
在临床试验行业里,从感性上讲,study比trial范围广,一提到trial,意识里基本上就是以注册为目的(所以都是有干预的)试验了,而一提到study,首先联想到的是不以注册为目的单纯的医学研究。
[1] (ICH E6 R2, 1.12) [2] https://clinicaltrials.gov/ct2/about-studies/learn
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