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Clinical researcher and patient connecting

Writing Clinical Trial Results for Multi-Regional Clinical Trials

Essential Considerations

Being a strong professional writer requires more than encyclopedic and professional knowledge. It’s a craft and technical discipline in language and communication. Additionally, writing always takes place in context, and, most importantly, an interaction between author and reader. Any text, including clinical trial results, should be written with an understanding of this context.

 

Styles of Clinical Trial Results Reporting

The reader-writer relationship is well defined in a scientific clinical trial report. Content follows a fixed format and often a timeline. As Stephen Pinker says in his book, The Sense of Style, this is a “practical writing style.”  The writer aims to satisfy the readers’ needs in this text style. Practical writing style contrasts with “classic style,” which takes any form or length, and the writer-reader relationship is often undefined or general.

The clinical trial report typically follows the ICH E3 guidance on Structure and Content of Clinical Study Reports. Medical writers create reports, and they’re trained in the medical community’s specific jargon and academic writing style. The intended reader is a professional peer, trained in the same communication style. For example, a regulatory scientific reviewer commonly reads these reports. In this context, the writer and reader are in well-defined roles.

Clinical researcher taking notes

However, when a medical writer authors a plain language summary of the same results, it brings different communication challenges. The intended reader may be any member of the public or a patient who participated in the trial. The reader may not have any prior knowledge or familiarity with jargon to leverage when interpreting the text. Also, most readers won’t have the necessary literacy skills to process medical language. In this type of plain style, content should therefore be, as Pinker says, “in full view, and the reader does not need any help in seeing anything.”

Producing Plain Language Summaries for Clinical Trial Results

Plain language summaries have become a standard requirement under the EU Clinical Trial Regulation published in 2014. Since then, different guidelines have been published on the content and style of such summaries. In 2021, a practical handbook on Good Lay Summary Practice (GLSP) was published on EudraLex volume 10.

Clinical researcher talking to a trial participant

The GLSP describes the multi-faceted skill set required to produce these plain language summaries. This includes several competencies:

  • Scientific knowledge (for example, on clinical research, disease, research methodology, and biomedical statistics)
  • Communication skills (for example, plain language writing/editing, unbiased writing, and health literacy principles)
  • Translation skills (including natural and target language skills, and translation process)
  • Visual design skills (for example, sound scientific graphic design principles and accessibility principles for visually impaired people)
  • Legal/compliance knowledge
  • Patient involvement insights

The recommendations provided in the GLSP guidance can be applied in other professions where technical content is re-written or summarized in plain language style. For example, plain language summaries are written within the finance or legal industries, with text created for industry professionals and non-professional readers. 

Get in touch 

Need language assistance for your multi-lingual clinical trial results communication? Lionbridge is a contributor to the GLSP handbook on language aspects. We have deep knowledge of life sciences translation services, clinical trial translation services, and plain language writing style. Contact us today to find out more about Lionbridge as a life sciences language service provider.  

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AUTHOR
Pia Windelov, VP of Life Sciences Strategy and Product Marketing
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