University of Oxford, Centre for Evidence-Based Medicine, Old Road Campus, Oxford, United Kingdom.
Am J Bioeth. 2009 Sep;9(9):34-48. doi: 10.1080/15265160903090041.
A resilient issue in research ethics is whether and when a placebo-controlled trial (PCT) is justified if it deprives research subjects of a recognized treatment. The clinicians' moral duty to provide the best available care seems to require the use of 'active' controlled trials (ACTs) that use an established treatment as a control whenever such a therapy is available. In another regard, ACTs are supposedly methodologically inferior to PCTs. Hence, the moral duty of the clinical researcher to use the best methods will favor PCTs. In this target article, I analyze the three reasons for believing that ACTs are inferior to PCTs namely: 1) ACTs lack 'assay sensitivity'; 2) ACTs do not measure absolute effect size; and 3) ACTs require more participants; and I contend that none are acceptable. Consequently the tension between clinical and research ethics dissolves: the moral duty of the clinician to avoid PCTs is unopposed by methodological considerations.
研究伦理中一个有争议的问题是,在剥夺研究对象已被认可的治疗方法的情况下,安慰剂对照试验(PCT)是否合理,以及在什么时候合理。临床医生提供最佳可用治疗的道德责任似乎要求在有可用治疗方法的情况下使用“活性”对照试验(ACT),将既定治疗方法作为对照。另一方面,ACT 在方法学上据称不如 PCT。因此,临床研究人员使用最佳方法的道德责任将有利于 PCT。在本文中,我分析了认为 ACT 不如 PCT 的三个原因,即:1)ACT 缺乏“检测灵敏度”;2)ACT 不测量绝对效果大小;3)ACT 需要更多的参与者;我认为这些原因都不可接受。因此,临床伦理和研究伦理之间的紧张关系得以化解:临床医生避免 PCT 的道德责任不受方法学考虑的反对。