Volume 26, Issue 3 - Observational Studies
ICMJE to mandate data sharing statements
Author: Stephen Gilliver
Abstract
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.
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.
Download the full article
References
- 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: http://www.ema.europa.eu/docs/envGB/document_library/Other/2010/11/WC500099473.pdf
- 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: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf
- 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://
- 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://
Visit the EMWA website
Search
Articles
Observations and Observational Studies
President's Message
EMWA News
RCTs: Can the treatment work? Patient registries: Does the treatment work?
Odd cases and risky cohorts: Measures of risk and association in observational studies
Guidance for the design and analysis of observational studies: The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative
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
Mentoring tomorrow’s medical writers
ICMJE to mandate data sharing statements
News from the EMA
Journal Watch
Getting Your Foot in the Door
In the Bookstores
Regulatory Matters
Medical Communications
The Webscout
Teaching Medical Writing
Good Writing Practice
Out on Our Own
Links
Editoral Board
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Deputy Managing Editor
Alicia Brooks Waltman
Associate Editors
Section Editors
AI/Automation
Biotechnology
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Publications
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Freelancing
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Layout Designer
Chris Monk