如何才能设计完美的临床试验?

How to design a perfect clinical trial?

规范的随机化临床试验目前已成为制定各种疾病诊疗指南的主要依据,但治疗方案的有效与否不仅与治疗方法有关,还取决于临床试验设计的完善性。2009年4月《美国医学会杂志》(JAMA)刊登了一篇有关认知行为疗法对早期的老年性广泛性焦虑症患者疗效的分析报告。我们经过仔细研读后,对影响治疗结果的主要因素进行了分析总结,指出了其在临床试验设计上存在的缺陷,我们的观点得到了编辑部和作者的认可,由此撰写的Letter发表于2009年8月的《JAMA》上。

Currently, most guidelines of disease diagnosis and therapy are mainly dependent on the standard randomized clinical trial （RCT）. However, the therapeutic efficacy doesn＇t only rely on the therapy itself, but also closely depends on the clinical trial design. One article entitled Cognitive behavior therapy for generalized anxiety disorder among older adults in primary care： a randomized clinical trial was published on JAMA, April 2009. After we read it in depth and pointed out several defects in their clinical trial design, which might influence the final conclusion. Our comments were accepted by the editors and authors quickly and published as letter on JAMA, August 2009.