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Medical jargon and specialized terminology can make clinical trials impossible to understand even when no language barrier is involved. A well-written lay summary can make valuable information accessible to everyone.

Congratulations! You’ve completed a groundbreaking clinical trial study that’s bound to improve a lot of lives around the world. Naturally, your colleagues and peers have no trouble understanding it, but it’s another story altogether for the average person. This is a huge potential problem, as institutions and funders are increasingly expecting their researchers to outline the impact of their research for the general public. Not only that, if you can transform your article into something that everyone can understand, you’ve got yourself a wider readership that’s more likely to share whatever it is that you’ve discovered. The key to accomplishing all this lies in producing a lay summary.

The point of a lay summary is to explain the results of a clinical study in simple language, so that the average reader can understand the study results. Lay summaries are strictly non-promotional, factual, and objective documents that complement other forms of clinical study disclosure, but do not replace them. So how do you go about producing one?

  • Justify your research. Nobody should ever question why you’ve done what you’ve done!
  • Give plenty of background and context to your research.
  • Use positive rather than negative sentences.
  • Try to include as many illustrations and graphics as possible.
  • Make sure your work follows a logical order.
  • Use the first-person narrative and the active voice.
  • Explain the impact of the work. Make sure everyone knows exactly what they can expect from it.
  • Use short sentences and write in plain English. Imagine you’re explaining your work to a family member or friend with no medical background.
  • Avoid jargon unless absolutely necessary, and explain it in detail if you do need to use it.
  • When you’re finished, ask a friendly non-academic to read it and check whether they understood it. If not, it’s time to go back to the drawing board.

Translating your lay summary

Properly translating your completed lay summary has never been more important than it is now. The EU Clinical Trials Regulation 536/ 2014 (EU CTR Article 37) mandates that:

  • Sponsors should submit a transparent, simplified summary of clinical trial results within a year of a trial being completed for studies in an adult population and within six months of trial completion for studies in a pediatric population.
  • The summaries need to be provided in all EU languages for countries in which the study has been conducted and have to be submitted (along with the summary of the clinical trial results) in the designated central EU portal and database, which in this case is the Clinical Trials Information System (CTIS).

Translating lay summaries requires the use of skilled linguists with clinical expertise in order to guarantee that the scientific integrity of the results is maintained. For starters, the translation memory (TM) used should be matched to customer terminology for consistency and accuracy. What’s more, the assessment should include forward and backward translations, a comparative review by an independent linguist, a clinical review by a subject matter expert, and a customer review.

When all things are considered, it’s easy to see why partnering with a language service provider that is ISO certified and ISPOR compliant is so important to the success of a clinical trial. At Argos Multilingual, we have the skills, the knowledge, the experience, and the qualifications to make sure that your simplified clinical trial content is comprehensible in the native languages of the principal investigator, the research teams, the subjects, and the general public. Visit us online to learn more about how we can shoulder the burden of regulatory compliance and help you breathe a little easier.

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