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The Rationale for Placebo-Controlled Trials: Methodology and Policy Considerations

机译:安慰剂对照试验的基本原理:方法和政策考虑

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摘要

Howick (2009) offers a salutary challenge to arguments regarding the methodological superiority of placebo-controlled trials (PCTs). It would take a detailed commentary to evaluate systematically the merits of his critique. Here I will confine my remarks to three issues: 1) the policy context of trial design aimed at evaluating new treatments for suitability in clinical practice; 2) sample size requirements for PCTs compared with active-controlled trials (ACTs); and 3) the value of small-scale "proof of concept" PCTs in the early phase of efficacy evaluation.
机译:Howick(2009)对安慰剂对照试验(PCTs)的方法学优势提出了质疑。需要系统地评估他的批评的优点的详细评论。在这里,我的发言仅限于三个问题:1)旨在评估新疗法在临床实践中的适用性的试验设计的政策背景; 2)与主动对照试验(ACT)相比,PCT的样本量要求; 3)小规模“概念验证” PCT在功效评估的早期阶段的价值。

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