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
. 2020 Jan 15;18(1):13.
doi: 10.1186/s12916-019-1481-8.

Can real-world data really replace randomised clinical trials?

Sreeram V Ramagopalan  1 , Alex Simpson  2 , Cormac Sammon  3
Affiliations
Comment

Can real-world data really replace randomised clinical trials?

Sreeram V Ramagopalan et al. BMC Med. .
No abstract available

Keywords: Effectiveness; Epidemiology; Randomised clinical trials; Real world data; Treatment.

PubMed Disclaimer

Conflict of interest statement

SVR has been an employee of pharmaceutical and life science consultancy companies. AS is an employee of Bristol-Myers Squibb. CS is an employee of PHMR.

Comment on

References

    1. Moscow JA, Fojo T, Schilsky RL. The evidence framework for precision cancer medicine. Nat Rev Clin Oncol. 2018;15:183. doi: 10.1038/nrclinonc.2017.186. - DOI - PubMed
    1. McDonald L, Lambrelli D, Wasiak R, Ramagopalan SV. Real-world data in the United Kingdom: opportunities and challenges. BMC Med. 2016;14:97. doi: 10.1186/s12916-016-0647-x. - DOI - PMC - PubMed
    1. Eichler HG, Koenig F, Arlett P, Enzmann H, Humphreys A, Pétavy F, et al. Are novel, nonrandomised analytic methods fit for decision-making? The need for prospective, controlled, and transparent validation. Clin Pharmacol Therapeut. 2019. 10.1002/cpt.1638. - PMC - PubMed
    1. Cave A, Kurz X, Arlett P. Real-world data for regulatory decision making: challenges and possible solutions for Europe. Clin Pharmacol Ther. 2019;106:36. doi: 10.1002/cpt.1426. - DOI - PMC - PubMed
    1. Anglemyer A, Horvath HT, Bero L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev. 2014;4:MR000034. - PMC - PubMed

LinkOut - more resources