Highlights ethical and safety concerns regarding the failure to disclose a faulty device in a regulatory trial for rivaroxaban.
Undisclosed device concerns in rivaroxaban trials erode trust in regulatory data; leaves open need for independent audits of trial integrity.
An investigation by The BMJ finds that companies were aware of concerns about a faulty device in a regulatory trial and reveals data that suggests participants were put at unnecessary risk. Deborah Cohen reports
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Deborah Cohen (2016) studied this question.
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