Layperson Summary in the EU published on Applied Clinical Trials
On July 11, 2017, Massimo Zaninelli, Erika Ornago, Elisa Sala e Antonio Ferrari published the peer reviewed paper Layperson Summary in the EU: Analysis of the Debate and Personal Remarks on the online magazine Applied Clinical Trials.
The article, based on the literature available today, deepens the regulatory bases that determine the future obligation (probably from 2019) for pharmaceutical companies to publish layperson summary of clinical trials related to their drugs. The layperson summary is a new type of document, provided by European Union Regulation 536/2014, expressly designed for those who do not have medical expertise. It outlines the assumptions, content, and results of a clinical trial.
The article, starting from the analysis of the readers’ motivations and features, proposes a critical review of the hierarchy of information contained in the layperson summary and formulates some recommendations about the writing to be adopted, emphasizing the centrality of the patient. It also describes the readability measurement techniques for different languages that the sponsors will have to use to ensure compliance with the layperson summary to EU legislation.
Lastly, the article describes the author’s experience and points out the main issues encountered in writing these texts.