- As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay persons. The regulation (CTR EU No 536/2014) obliges the company to produce this summary of results for the lay audience one year after the end of the trial in the EU.
- This regulation is a major step forwards in transparency. It is an opportunity to explain drug development, and hopefully to increase public awareness and understanding of the pharmaceutical industry.
- The preparation of a lay summary however presents the unique challenge of making sure that it is understandable to a layperson. The lay audience is not used to reading scientific information or scanning tables for messages the way people in the industry are. Plain language is essential. Scientific, medical and statistical jargon should not be used, or at least should be explained in plain language in addition to the technical term.
- Trilogy will help you to produce a clear, undaunting and concise lay summary, conveying crucial and complex information in a form that can be understood by a layperson.