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ResourcesHuman Research EthicsMove clinical trial data sharing from an option to an imperative – STAT (Rebecca Li | February 2019)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Move clinical trial data sharing from an option to an imperative – STAT (Rebecca Li | February 2019)

 


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Data from clinical trials have long been locked away, some in this principal investigator’s computer bank, some in that pharmaceutical company’s cloud. For years we have been talking about opening up those vaults and freeing these data. The key has finally turned: Data sharing is becoming the new reality.

From Jan. 1, 2019, onward, the world’s leading medical journals, including the New England Journal of Medicine, the Lancet, Annals of Internal Medicine, BMJ, and thousands more require authors to disclose whether and how they plan to share deidentified raw data from individual participants in their clinical trials. What’s more, researchers wishing to publish in these journals must declare their data-sharing plans in a public registry, such as ClinicalTrials.gov.

It’s a radical departure from where we’ve been. In my former life conducting trials as a scientist in industry and for the National Institutes of Health, when I’d log onto ClinicalTrials.gov to register a new trial, I didn’t have to give a second thought to if or how I’d be sharing data from the trial. Now all researchers need to think about that from the very beginning, even before the first trial participant is enrolled.

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