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Guidance and important steps to consider when writing lay summaries

Lay summary guidance

Sponsors of clinical trials are required to provide result summaries in a format that is understandable to laypersons, as outlined in the EU Clinical Trials Regulation 536/2014 (Article 37) (EU CT Regulation). After a period of public consultation, the EU’s guidance ‘Summaries of clinical trial results for laypersons’ was published in January 2017. Recently, Theo Raynor, Professor of Pharmacy Practice at the University of Leeds, has written an article summarising the guidance and outlining the important steps to consider when writing such a critical piece of commentary.

Raynor points out the difference that “lay-friendly headings” make to the readability of the article and that although the piece should be concise and kept as short as possible, this should not be to the detriment of technical explanations. Layout and design can be used to guide the reader through a lengthier document. He suggests that a conversational approach to writing should be adopted as many lay people “communicate by talking, listening to conversations, the radio and television” rather than through reading and writing. The use of graphics or visuals should be carefully considered, as even simple graphs can be misinterpreted. Raynor finishes with the reiteration that the document provided by the European Commission is for guidance purposes and should not deter writers from using “innovation in improving summaries’ usefulness”.



Summary by Jo Chapman, PhD from Aspire Scientific

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One thought on “Guidance and important steps to consider when writing lay summaries Leave a comment

  1. I think summaries of clinical trial plans (funding applications and protocols) should also be mandated in the regulations. The summaries currently on the HRA website are available if you look really hard… ( The information contained within the research summaries is extracted from the researcher’s/sponsor’s application form, so are unreadable – definitely not conversational or in language laypeople can understand. There is a great opportunity here to create understandable summaries of planned and ongoing research which could then be explicitly linked to the lay summary of the results. This would be a great step towards transparency and public understanding of the research process. It could also be another route way to recruit trial participants, or encourage patient and public involvement in the design and conduct of the research.

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