Sharing Biomedical Data – ICMJE Proposal and Responses Briefing

Note: This last week has been *highly* entertaining as I’ve been watching reactions and interactions surrounding a new proposal for sharing of clinical trial data.  I’ve sent this as a briefing around interested parties at my library and thought it might be useful if you’re trying to find the thread. My goal is to hit some of the major highlights. If there’s a particularly salient response I’m missing, please let me know! (As far as I know, all of these articles are available openly.)

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Last week the International Committee of Medical Journal Editors proposed new rules on data sharing for clinical trials. The statement that first caught my eye was a proposal for patient-level de-identified data to be shared within 6 months post-publication. There’s much more to it, of course, but that one was particularly of interest.

Full Text from Annals of Internal Medicine: http://annals.org/article.aspx?articleid=2482115&resultClick=3

“Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors”

• Press Release: http://www.eurekalert.org/pub_releases/2016-01/acop-lmj011916.php

This, rather promptly sparked a response from the EIC and an AE of NEJM which includes a description of those who reuse data as “research parasites”

• Editorial from NEJM: Data Sharing http://www.nejm.org/doi/full/10.1056/NEJMe1516564

As you can imagine, the editorial got a lot of attention– a couple of interesting blog posts on that front:

• Research “parasitism” and authorship rights https://forbetterscience.wordpress.com/2016/01/22/research-parasitism-and-authorship-rights/
• Fundamental Difference of Opinion https://practicaldatamanagement.wordpress.com/2016/01/22/a-fundamental-difference-of-opinion/

Which then meant by Monday there was a further editorial from the EIC at NEJM that sort of clarifies but also is broadsweepingly negative about data scientists

•  Data Sharing and the Journal  http://www.nejm.org/doi/full/10.1056/NEJMe1601087

Again, there was response:

• Translation to plain English of NEJM clarification on data sharing |
  http://jonathanpeelle.net/blog/2016/1/25/translation-to-plain-english-of-nejm-clarification-on-data-sharing
• International Society for Computational Biology responds: ISCB Responds to New England Journal of Medicine Article http://news.iscb.org/2016/01/iscb-responds-to-new-england-journal-of.html

And on a more public side, this piece in NPR:

• Journal Editors To Researchers: Show Everyone Your Clinical Data
  http://www.npr.org/sections/health-shots/2016/01/26/464010931/journal-editors-to-researchers-show-everyone-your-clinical-data

 

Now then, to start sorting what infrastructure and policy we’re going to need to meet these new requirements… get your comment in to ICMJE by April!