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Three Challenges in Creating Plain Language Summaries of Clinical Trial Results



For years, the scientific community has prepped and planned for the production of plain language summaries (PLSs) of clinical trial results. As part of EU CTR 536/2014, sponsors must submit PLSs – i.e., documents that an average person without a scientific background could easily understand – of their trial results (1). The impetus behind this regulation has been the largely theoretical push for greater transparency. A 2019 Pharmaceutical Medicine article notes that: “Study participants, advocacy groups, and, to a lesser extent, the general public have called for greater transparency in their quest for information on clinical studies” (2).

Over the past year, the COVID-19 pandemic has underscored the demand for such transparency. This global pandemic has served as a case study in the importance of producing scientific information that the public can readily digest. As the world has collectively waited for COVID-19 vaccines and/or treatments, the results of clinical trials have become more interesting and relevant to non-scientific communities than ever before. As Parexel noted in a recent blog post: “Providing a PLS is even more crucial in this global health crisis, where in excess of 100 clinical research studies are being carried out to find a new drug – either to prevent or treat COVID-19” (3).

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About the Author


Wendy Farrell is the Senior Director of Content Development for RWS’s Regulated Industries division. In this role, she leads a team that creates and delivers compelling life science content, including articles, presentations, white papers, research, and thought leadership for professionals in highly regulated industries. With over 15 years spent in the localisation industry, Wendy has collaborated with experts and helped organisations build more meaningful connections with their global audiences, through her background in global marketing, sales, solution development, multimedia, and training.

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