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
. 2018 Jul 11:7:1054.
doi: 10.12688/f1000research.15517.1. eCollection 2018.

Time to really share real-world data?

Affiliations

Time to really share real-world data?

Sophie Graham et al. F1000Res. .

Abstract

Data other than that from clinical trials are important for healthcare decision making. However, unlike the vocal calls seen for more open access to trial data, there are limited efforts being made to ensure that agencies that collect real-world data (RWD) share this, despite its importance. There are many RWD sources across the world that could be readily exploited for research once shared. There are policy and privacy questions that need to be tackled, but opening up and sharing RWD offers remarkable potential for improvements in care for individuals and more effective use of limited healthcare resources. Open science should become the standard for RWD as well as clinical trials, especially those that have a high likelihood to influence practice.

Keywords: clinical data; real-world data; sharing.

PubMed Disclaimer

Conflict of interest statement

Competing interests: SG and RW are employees of Evidera. LM, ML and SR are employees of Bristol-Myers Squibb.

References

    1. McDonald L, Lambrelli D, Wasiak R, et al. : Real-world data in the United Kingdom: opportunities and challenges. BMC Med. 2016;14(1):97. 10.1186/s12916-016-0647-x - DOI - PMC - PubMed
    1. Jarow JP, LaVange L, Woodcock J: Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data. JAMA. 2017;318(8):703–704. 10.1001/jama.2017.9991 - DOI - PubMed
    1. Freemantle N, Richardson M, Wood J, et al. : Weekend hospitalization and additional risk of death: An analysis of inpatient data. J R Soc Med. 2012;105(2):74–84. 10.1258/jrsm.2012.120009 - DOI - PMC - PubMed
    1. Ebrahim S, Sohani ZN, Montoya L, et al. : Reanalyses of Randomized Clinical Trial Data. JAMA. 2014;312(10):1024–1032. 10.1001/jama.2014.9646 - DOI - PubMed
    1. Guinney J, Wang T, Laajala TD, et al. : Prediction of overall survival for patients with metastatic castration-resistant prostate cancer: development of a prognostic model through a crowdsourced challenge with open clinical trial data. Lancet Oncol. 2017;18(1):132–142. 10.1016/S1470-2045(16)30560-5 - DOI - PMC - PubMed

LinkOut - more resources