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June 6, 2001

Informing Patients of Uncertainty in Clinical Trials—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;285(21):2713-2714. doi:10.1001/jama.285.21.2713

In Reply: All clinical research should be conducted to resolve existing uncertainty and, in the case of uncertainty about the relative value of interventions, the appropriate research design is usually an RCT. If there were no uncertainty, there would be no clinical research. It is that simple, and the resolution of uncertainty should be the main purpose of clinical trials.1 It follows then that the method for resolution of the uncertainty should be linked to the question about that uncertainty. This uncertainty should reflect the knowledge and values of the people taking part in the trial and, as we point out, should ideally be based on a prior systematic review of existing evidence. It is not true that, according to the uncertainty principle, it is only the individual physician's views that should be considered. When discussing an RCT with participants, explicit acknowledgment of uncertainty is probably the best means available to explore the views of participants about the relative effects of the interventions under investigation. It represents a moral basis for a trial.2 How much uncertainty should exist prior to a trial and whose uncertainty should count remain unsettled.3

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