The Conflict Between Randomized Clinical Trials and the Therapeutic Obligation
Journal of Medicine and Philosophy. 1986 Nov; 11(4): 347-366.
The assumption that randomized clinical trials are the best way to get reliable knowledge about the efficacy of treatments leads to conflict with the physician's therapeutic obligation to treat patients in the way that will be most beneficial to them. This dilemma arises whenever the evidence for the superiority of one treatment is approaching, but has not yet reached, the significance level. Considerations of different ways of obtaining informed consent, determining ways of minimizing harm, and justifications for violating the therapeutic obligation are discussed but found unsatisfactory in many respects. Contract models of justifying randomized trials seem to be the most promising models to assess; however, more research is needed on the methodologies of human experimentation to determine whether some combination of random and historical controls or some statistical or procedural changes could give reliable results with less harm to patients. (KIE abstract)
Clinical Trials; Contracts; Costs and Benefits; Consent; Decision Making; Harm; Human Experimentation; Informed Consent; Justice; Knowledge; Moral Obligations; Patients; Physician's Role; Public Policy; Random Selection; Research; Research Design; Resource Allocation; Risks and Benefits; Utilitarianism;
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Gifford, Fred (1995-04)This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clincial trials (RCTs) -- the "community equipoise" strategy (CE). The dilemma is that RCTs appear ...