Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comment
. 2021 Jan;18(1):7-8.
doi: 10.1038/s41571-020-00448-y.

Pragmatic trials with prespecified subgroups: what oncologists can learn from COVID-19

Affiliations
Comment

Pragmatic trials with prespecified subgroups: what oncologists can learn from COVID-19

Rahul Banerjee et al. Nat Rev Clin Oncol. 2021 Jan.

Abstract

Randomized controlled trials designed to test cancer therapies often fail to clarify effectiveness in real-world settings. Herein, we explore lessons for trial development in oncology that can be learnt from the large-cohort, pragmatic RECOVERY trial involving patients hospitalized with COVID-19.

PubMed Disclaimer

Conflict of interest statement

V.P. has acted as a consultant of UnitedHealthcare, has received research funding from Arnold Ventures, has received royalties from Johns Hopkins Press and Medscape, has received speaker’s fees from Evicore and for Grand Rounds/lectures from various universities, medical centres, non-profit organizations, and professional societies and has received financial support for the Plenary Session series of podcasts via Patreon. R.B. declares no competing interests.

Comment on

  • Dexamethasone in Hospitalized Patients with Covid-19.
    RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. RECOVERY Collaborative Group, et al. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17. N Engl J Med. 2021. PMID: 32678530 Free PMC article. Clinical Trial.

References

    1. Templeton AJ, Booth CM, Tannock IF. Informing patients about expected outcomes: the efficacy-effectiveness gap. J. Clin. Oncol. 2020;38:1651–1654. doi: 10.1200/JCO.19.02035. - DOI - PubMed
    1. Group RC, et al. Dexamethasone in hospitalized patients with Covid-19 - preliminary report. N. Engl. J. Med. 2020 doi: 10.1056/NEJMoa2021436. - DOI
    1. Konrat C, et al. Underrepresentation of elderly people in randomised controlled trials. The example of trials of 4 widely prescribed drugs. PLoS ONE. 2012;7:e33559. doi: 10.1371/journal.pone.0033559. - DOI - PMC - PubMed
    1. Singh H, et al. FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: a 10-year experience by the U.S. Food and Drug Administration. J. Clin. Oncol. 2017;35(suppl. 15):10009. doi: 10.1200/JCO.2017.35.15_suppl.10009. - DOI
    1. Ford I, Norrie J. Pragmatic trials. N. Engl. J. Med. 2016;375:454–463. doi: 10.1056/NEJMra1510059. - DOI - PubMed