Clinical Trial Lay Summaries – a unique chance for transparency
The Clinical Trials Regulation (CTR EU No 536/2014) is directly applicable in all EU/EEA Member States and obliges clinical trial sponsors to prepare a summary of the results of every clinical trial for the non-specialist/ general public audience. Mandatory as of 31 January 2022, this Lay Summary must be uploaded to the Clinical Trials Information System (CTIS) at the latest one year after the end of the trial (6 months for paediatric studies).
This regulation is a major step forwards in transparency. It is an opportunity to explain drug development to the general public, and hopefully to increase public awareness and understanding of the pharmaceutical industry.
Trilogy helps clinical trial sponsors to prepare Lay Summaries that are compliant with CTR EU No 536/2014, using the highest ethical standards and medical writing best practices.
Lay Summaries – simple, but not easy
The preparation of a Lay Summary presents the unique challenge of making sure that complex clinical information is understandable to the general public. This audience is not used to reading scientific information or scanning tables and graphs for messages. Plain language is essential. Scientific, medical, and statistical jargon should be explained in plain language and given in context to allow the reader to understand its meaning. And all of this should be done in a compact, easy to read, and digestible document.
TriloTake on Lay Summaries
Listen to Lisa Chamberlain James, Senior Partner at Trilogy, talk about her take on Lay Summaries – what are the opportunities and what are the challenges?
Understand science. Communicate effectively. You need to do both.
“If you can’t explain it simply, you don’t understand it well enough.” Albert Einstein
Trilogy are specialists. As professional medical writers, we not only routinely produce regulatory documentation, but have the in-depth understanding and skill set to be able to ‘translate’ this for the general public. We will help you to produce a clear, undaunting, accurate, compliant, and concise Lay Summary, conveying crucial and complex scientific information in a form that can be understood by anyone.
Summaries for the general public are not new – they are also required as part of the Risk Management Plan (RMP) and are increasingly being asked for by scientific journals (Plain Language Summaries of Publications – PLSPs). In some countries, plain language summaries of clinical trial protocols are also required.
Whatever your need for information for the general public, Trilogy has the expertise to help.