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The evolution of regulations for improved clinical trial transparency

Evolution of clinical trial data sharing regulations

The ongoing push towards increased transparency around clinical trials has seen the evolution of regulatory requirements for data reporting and sharing in Europe and the US over the past decade. In a recent issue of “The MAP Newsletter” from the International Society for Medical Publication Professionals (ISMPP), Antonia Panayi and Slavka Baronikova (Shire International) discussed key developments in these regulations, and their potential implications for those working in medical publications.

The authors began by describing the standards set out by the European Medicines Agency (EMA) to increase the accessibility of clinical trial information, including Policy 0070, under which the EMA publicly discloses clinical data submitted as part of market authorisation applications. The second phase of this policy will focus on the sharing of individual patient data and the authors highlight the recent recommendations from the International Committee of Medical Journal Editors regarding this, as well as approaches already being undertaken by some pharmaceutical companies, such as publication via centralised scientific review boards.

Further guidelines and recommendations aimed at increasing the transparency of trial-related information, including for investigational medicinal products that do not have marketing authorisation, are being revised under the EU Regulation No. 536/2014. From 2018, this regulation will include a requirement to provide a publicly available results summary and lay-person summary for all clinical trials within one year of study completion. A centralised EU database for publication of this information is under development, expected to go live in September 2018 (EudraCT will be used until then).

In the US, the “Final Rule”, a transparency initiative from the National Institutes of Health, has clarified and expanded upon the reporting requirements set out in the Food and Drugs Administration Act 2007. This includes additional requirements effective this year for study registration and summary information, including publication of a full protocol and statistical analysis plan.

Panayi and Baronikova suggest that adherence to these evolving EU and US regulations will require ongoing coordinated efforts from publications professionals, study sponsors and other relevant stakeholders, to ensure complete and timely reporting of clinical data. They conclude that the resultant increased transparency and data access will be beneficial to patients, healthcare professionals and researchers alike.


Summary by Alice Wareham, PhD from Aspire Scientific

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