Medical Writing Public Disclosure Clinical trial disclosure and transparency

Volume 27, Issue 2 - Public Disclosure

Clinical trial disclosure and transparency


The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure of
clinical trials in public databases has progressed to a new level, encompassing not only registration of new trials but also the disclosure of summary results for completed clinical trials for all drugs investigated in clinical trials, irrespective of their marketing approval status. Further development currently being implemented is the sharing of de-identified/anonymised trial participant data sets, thereby enabling re-analysis.
The Regulation EU No. 536/2014 is an EU law that instructs trial sponsors on the organisational, reporting, and disclosure aspects of clinical trials. The content of Regulation EU No. 536/2014 is intertwined with other obligations relevant to clinical trial disclosure and transparency efforts. Overlaps of the Regulation EU No. 536/2014 to other pertinent laws, policies, or required practices are summarised in this article, and some
practical examples are provided for stake - holders who are involved in the planning, evaluation, and preparation of documents relevant to clinical trials.

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President’s Message
The Regulatory Public Disclosure Special Interest Group
Clinical trial disclosure and transparency
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 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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