Schwartz Daniel, Lellouch Joseph
Unité de Recherches Statistiques, Institut National de la Santé et de la Recherche Medicale, Villejuif, France.
J Clin Epidemiol. 2009 May;62(5):499-505. doi: 10.1016/j.jclinepi.2009.01.012.
It is the thesis of this paper that most therapeutic trials are inadequately formulated, and this from the earliest stages of their conception. Their inadequacy is basic, in that the trials may be aimed at the solution of one or other of two radically different kinds of problem; the resulting ambiguity affects the definition of the treatments, the assessment of the results, the choice of subjects and the way in which the treatments are compared. It often occurs that one type of approach is ethically less defensible than the other, or may even be ruled out altogether on ethical grounds. We postpone consideration of this aspect of the question until a later section.
本文的论点是,大多数治疗试验从构思的最初阶段起就制定得不够完善。它们的不完善是根本性的,因为试验可能旨在解决两种截然不同类型问题中的一种或另一种;由此产生的模糊性影响治疗方法的定义、结果的评估、受试者的选择以及治疗方法的比较方式。经常会出现一种方法在伦理上比另一种方法更难辩护的情况,甚至可能基于伦理理由被完全排除。我们将这个问题的这一方面的讨论推迟到后面的部分。