Cluster over individual randomization: are study design choices appropriately justified? Review of a random sample of trials.

Monica Taljaard Cory E GoldsteinBruno GiraudeauStuart G NichollsKelly CarrollSpencer Phillips HeyJamie C BrehautVipul JairathAlex John LondonSandra M EldridgeJeremy M GrimshawDean A FergussonCharles Weijer

Published in: Clinical trials (London, England) (2020)

Rationales for adopting cluster over individual randomization and for adopting consent waivers are emerging, related to the need to facilitate pragmatic trials. Greater attention to clear reporting of study design rationales, informed consent procedures, as well as justification for waivers is needed to ensure that such trials meet appropriate ethical standards.

Keyphrases

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study protocol
emergency department
randomized controlled trial
adverse drug