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To the Editor: Drs Djulbegovic and Clarke mistakenly suggest that the "fundamental ethical challenge" of equivalence trials is that they entail an a priori assumption that one intervention is superior to another.¹

The authors claim that "[t]he design of a clinical trial should be a function of the uncertainty principle," while simultaneously acknowledging that "prior research should not have proved a difference between the alternate therapies in outcomes to be assessed." But according to the uncertainty principle, only the individual physician's views, and not prior knowledge, should be considered.² Among the problems with this principle are that it does not explain what counts as medical knowledge, where medical knowledge comes from, or what is the purpose of a randomized controlled trial (RCT).³ It is therefore inadequate to answer questions about scientific design.

Djulbegovic and Clarke suggest that, in equivalence RCTs, investigators should inform participants that the new drug is assumed . . . [Full Text of this Article]

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