Medical Writing Public Disclosure Editorial
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Volume 27, Issue 2 - Public Disclosure

Editorial

Abstract

A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.

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References

  1. European Medicines Agency Clinical Data website, Available from: https://clinicaldata.ema.europa.eu/web/cdp/home
  2. Sharfstein JM, Miller JD, Davis JS, et al. Blueprint for transparency at the U.S. Food and Drug Administration: recommend - ations to advance the development of safe and effective medical products. The Journal of Law, Medicine & Ethics. 2017;45(4 Suppl):7-23. Available from Available from: https://www.jhsph.edu/departments/health-policy-and-management/blueprint-for-transparency-at-the-food-and-drug-administration/1.pdf
  3. Public release of clinical information. Health Canada. Current Status: Ongoing technical consultations and public consultation on draft changes to the Food and Drug Regulations and the Medical Device Regulations. Available from Available from: https://www.canada.ca/en/health-canada/programs/consultation-public-release-clinical-information-drug-submissions-medical-device-applications.html?wbdisable=true
  4. Drug Approval Package: ERLEADA (apalutamide). Available from Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/Erleada_210951_toc.cfm
  5. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. Trials. 2010; 11:9.
  6. Recommendations for the Conduct, Report ing, Editing, and Publication of Scholarly work in Medical Journals. Dec 2017. Available from: http://www.icmje.org/icmje-recommendations.pdf
  7. CORE (Clarity and Openness in Reporting: E3-based) Reference: An Open Access Resource to Support Authoring of Clinical Study Reports for Interventional Studies. 2016. Available from: http://www.core-reference.org/media/1032/core-reference-v1_0.pdf

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Articles

Editorial
President’s Message
EMWA News
The Regulatory Public Disclosure Special Interest Group
Clinical trial disclosure and transparency
Clarity and Openness in Reporting: E3-based (CORE) Reference
Navigating the EMA clinical data website
Anonymisation reports from 2016 to 2017: A preliminary analysis
Preparing anonymisation reports in general and for an orphan drug in particular
Policies 0070 and 0043: Juggling different requirements
Clinical data publication by the EMA: The challenges facing the pharmaceutical industry
Clinical trial results disclosure on ClinicalTrials.gov and EudraCT
Writing lay summaries: What medical writers need to know
Lay titles for clinical trials: A balancing act
Why clinical study reports really matter
CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure
Preparing clinical study reports for external sharing
Harmonising format and style requirements for scientific and medical publications
News from the EMA
Winners of the Geoff Hall Scholarship Essay Competition
Creative medical writing: An oxymoron?
Creative medical writing - An oxymoron?
An interview with Chris Winchester
Journal Watch
In the Bookstores
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Out on Our Own
Upcoming issues ofMedical Writing

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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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