Antiepileptic drug randomized controlled trial (RCT) design has been criticized for its emphasis on regulatory, licensing aspects rather than clinical considerations. A new study that scrutinized RCT patient recruitment has also raised important ethical issues. At a time when RCT patient recruitment in resource-poor countries is increasing, changes in RCT design seem imperative.
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Lhatoo, S., Lüders, H. Drug trial design and epilepsy surgery: time for a change?. Nat Rev Neurol 6, 475–476 (2010). https://doi.org/10.1038/nrneurol.2010.116
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DOI: https://doi.org/10.1038/nrneurol.2010.116
