A new study, published in the journal Vaccine, has sought to understand the potential of the European Clinical Trial Regulation No 536/2014 (also called the EU CTR regulation) to inform the general public about vaccine clinical research. This regulation starts in January 2022 and means that anyone carrying out a clinical trial in Europe is required to provide a short, easy to read, non technical summary of the trial results. So studies looking into the potential impact of these plain language summaries will help trial sponsor understand what is needed when preparing these summaries.
In the study, the researchers carried out two surveys to look at what the public expects from plain language summaries. In survey 1, participants were asked about their interest in and what they expect from vaccine study results. In survey 2, the researchers asked participants their preferences on how the results of these studies were presented in a range of different format of plain language summaries.
The results from survey 1 showed that people with the highest level of vaccine knowledge had the highest level of trust in vaccine information. Healthcare professionals were the most trusted source for vaccine information. From survey 2, infographic-style formats of plain language summaries rated the highest and were the considered easiest to understand.
In summary, the authors conclude that plain language summarise have the potential to increase health literacy and build trust, knowledge and confidence in vaccine research.
The article, called ‘Improving knowledge and trust in vaccines: A survey-based assessment of the potential of the European Union Clinical Trial Regulation No 536/2014 plain language summary to increase health literacy’ can be read in full here.