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. 2021 Apr 22;384(16):1572-1573.
doi: 10.1056/NEJMc2102446.

Platform Trials - Beware the Noncomparable Control Group

Affiliations

Platform Trials - Beware the Noncomparable Control Group

Lori E Dodd et al. N Engl J Med. .
No abstract available

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Figures

Figure 1
Figure 1. Hypothetical Example of How Nonconcurrent Randomization Could Bias the Results of a Trial.
Panel A shows the 30-day in-hospital mortality from Covid-19 in April 2020 (12.9% [SE, 0.3]), in May 2020 (5.9% [SE, 0.2]), and over both months (9.3 [SE, 0.2]) (data are from eFig. 2B in Asch et al.). Panel B shows the data from a hypothetical trial for an ineffective new agent used in May 2020 as compared with a control treatment used in April and May 2020. The data show that mortality was lower by 37% with the ineffective new agent than with the control treatment.

References

    1. Freidlin B, Korn EL, Gray R, Martin A. Multi-group clinical trials of new agents: some design considerations. Clin Cancer Res 2008;14:4368-4371. - PubMed
    1. Asch DA, Sheils NE, Islam MN, et al. Variation in US hospital mortality rates for patients admitted with COVID-19 during the first 6 months of the pandemic. JAMA Intern Med 2020. December 22 (Epub ahead of print). - PMC - PubMed
    1. Korn EL, Freidlin B. Outcome — adaptive randomization: is it useful? J Clin Oncol 2011;29:771-776. - PMC - PubMed
    1. Angus DC, Derde L, Al-Beidh F, et al. Effect of hydrocortisone on mortality and organ support in patients with severe COVID-19: the REMAP-CAP COVID-19 corticosteroid domain randomized clinical trial. JAMA 2020;324:1317-1329. - PMC - PubMed
    1. The REMAP-CAP Investigators. Interleukin-6 receptor antagonists in critically ill patients with Covid-19. N Engl J Med. DOI: 10.1056/NEJMoa2100433. - DOI - PMC - PubMed

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