Medical Writing Observational Studies ICMJE to mandate data sharing statements

Volume 26, Issue 3 - Observational Studies

ICMJE to mandate data sharing statements


Those of us who attended the 2017 spring conference in Birmingham were treated to an excellent symposium on transparency in clinical trials, where EU Policy 00701 on disclosure of clinical data was a key focus. A month later, the
ICMJE (International Committee of Medical Journal Editors) announced that beginning in July 2018 they will require that submitted manuscripts based on clinical trials carry a data sharing statement.2Data sharing statements will be expected to describe the following: whether data will be shared; what will be shared; and when and for how long the data will be available.3 Also, from 2019 new trials will have to include a data sharing plan in their registration information.
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  1. European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use). POLICY/0043. European Medicines Agency. 2010 Nov 30 [cited 2017 Jul 24]. Available from: Available from:
  2. European Medicines Agency policy on publication of clinical data for medicinal products for human use. European Medicines Agency. 2014 Oct 02 [cited 2017 Jul 24]. Available from: Available from:
  3. Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A et al. Data sharing statements for clinical trials: A requirement of the International Committee of Medical Journal Editors. PLoS Med 2017;14:e1002315. Available from: http://
  4. Bierer BE, Crosas M, Pierce HH. Data authorship as an incentive to data sharing. N Engl J Med 2017;376:1684–7. Available from: http://



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Guidelines for disclosing the results from observational trials
Registration and ethics committee approval for observational studies: Current status and way forward
Regulatory submissions of non-interventional post-authorisation safety studies
Reporting non-interventional post-authorisation safety studies (NI-PASS)
Patient-reported outcomes: How useful are they?
EMA releases the revised Good Pharmacovigilance Practices Module V – updated guidance on risk management plans
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ICMJE to mandate data sharing statements
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