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French, Jacqueline A
"Trial Design: How Do We Figure Out if an AED Works"
Epilepsy currents 2012 Jan; 12(1):24-26
Regulatory trials rigorously test the ability of a treatment to impact a known outcome, such as seizure frequency, as measured in well-controlled trials. Such outcomes are called efficacy outcomes. Sometimes these measured outcomes do not reflect the true effectiveness of the drug in the clinic. This article provides some examples of how this can happen and also discusses trials intended to measure effectiveness.

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