Clinical Trial Results Summary for Laypersons: A User Testing Study

In Europe, clinical trial sponsors will soon be required by the new EU Clinical Trials Regulation to publish a public summary of clinical trial results. This needs to happen within 1 year of the trial ending, and so in advance of this requirement, companies across the industry are hard at work to ensure they are ready for the application of the new regulation – currently anticipated for the second half of 2019.

Luto and the pharma company Merck have just published the results of a user testing study (sometimes called ‘readability testing’) which has informed the public consultation on the Commission guidelines for clinical trial lay summaries. Published in Therapeutic Innovation & Regulatory Science (the journal of the Drug Information Association) the work shows how health literate summaries can be enhanced through the application of  user testing. Read more here.

At the time of testing, little guidance was available on how to create such summaries. We therefore set out to maximise the readability and acceptability of a sample laypersons’ summary developed by the Merck team. We aimed to determine whether this summary met laypeople’s needs, including those with a range of health literacy levels.

This sample clinical trial layperson’s summary was developed iteratively during the study – informed by the draft guidance on writing such summaries (that was subsequently published) and by implementing learnings from user testing with the target audience. The study identified ways in which health-literate summaries can be produced and outlines considerations for both content and layout that authors may want to take on board when preparing lay summaries.

A notable issue was the question of a bar chart which posed difficulties to some participants:

One said ‘Why is it upside down?’ – and this immediately highlighted that this format would be confusing for lay people who are not used to such charts. Hence the final version of the summary included this revised version (which was the ‘right way up’) which tested well.

The final guideline has now been published by the EMA. This guideline recommends that where feasible, sponsors should consider testing the readability of summaries with a small number of people who represent the target population.

Please contact Kirstin Blackwell if you would like to talk with us about how we may apply user testing methods to enhance your lay summaries.

Professor Theo Raynor, lead author and academic advisor to Luto Research said ‘This study is a perfect example of how getting members of the public involved in testing can enhance their readability in a way that no other methods can. We first get the participants to see if they can find and explain key points of information, they then give us feedback on where and why there were difficulties – and we then apply good practice to resolve those issues.’