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. 2024 Dec;20(12):1555-1558.
doi: 10.1200/OP.24.00217. Epub 2024 Jul 10.

Two-to-One Randomization: Rarely Advisable

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Two-to-One Randomization: Rarely Advisable

Boris Freidlin et al. JCO Oncol Pract. 2024 Dec.

Abstract

In a randomized clinical trial, instead of allocating patients equally between the treatment arms, some trials in oncology assign a higher proportion of patients to receive the experimental treatment arm (eg, a two-to-one randomization). In this commentary, we first briefly review the common reasons given for the use of a two-to-one randomization and provide some examples of trials using these designs. We then explain why the risk-benefit ratio of this approach may not be favorable as is commonly assumed.

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References

    1. Jenei K, Haslam A, Olivier T, Miljkovíc M, Prasad V. What drives cancer clinical trial accrual? An empirical analysis of studies leading to FDA authorisation (2015–2020). BMJ Open. 12(10)), 2022 - PMC - PubMed
    1. Donovan JL, Lane JA, Peters TJ, et al.: Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epid 62:29–36, 2009 - PubMed
    1. Avins AL. Can unequal be more fair? Ethics, subject allocation, and randomised clinical trials. J Med Ethics. 24(6):401–8, 1998 - PMC - PubMed
    1. Hey SP, Kimmelman J: The questionable use of unequal allocation in confirmatory trials. Neurology 82: 77–79, 2014 - PMC - PubMed
    1. Zhou C, Solomon B, Loong HH, et al.: First-line selpercatinib or chemotherapy and pembrolizumab in RET Fusion–Positive NSCLC. N Engl J Med 389: 839–1850, 2023 - PMC - PubMed

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