Hansson Sven Ove
Department of Philosophy and the History of Technology, Royal Institute of Technology, Teknikringen 78, 100 44 Stockholm, Sweden.
Theor Med Bioeth. 2006;27(2):149-67. doi: 10.1007/s11017-006-0001-y.
A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. The indecisiveness of our criteria for cautious decision-making under uncertainty creates the leeway that makes clinical trials defensible.
本文给出了对临床试验中均衡性和不确定性的概率性阐释。为了在临床试验的正当性论证中发挥作用,均衡性必须根据可能治疗结果的重叠概率分布来解释,而不是用代表期望值的点估计。治疗结果的不确定性被证明是临床试验伦理可辩护性的必要但不充分条件。针对该不确定性的性质提出了额外要求。我们在不确定性下谨慎决策标准的不确定性创造了使临床试验具有可辩护性的回旋余地。