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

CONCLUSION: 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.
PMID: 32367741 [PubMed - as supplied by publisher]

Source: Clinical Trials - May 4, 2020 Category: Research Authors: Taljaard M, Goldstein CE, Giraudeau B, Nicholls SG, Carroll K, Hey SP, Brehaut JC, Jairath V, London AJ, Eldridge SM, Grimshaw JM, Fergusson DA, Weijer C Tags: Clin Trials Source Type: research