Public Consultation
Good Lay Protocol Synopsis Practice
Are you ready to make clinical trial information more accessible and understandable for everyone? This document was created to do exactly that! It offers practical recommendations for crafting the Lay Protocol Synopsis (LPS) required by the Clinical Trial Regulation (CTR) in Europe (EU and EEA). It was developed by the Good Lay Summary Practice (GLSP) initiative in collaboration with other leading experts.
Our goal is to provide detailed, actionable advice that goes beyond the existing Question and Answers (Q&A) document (version 7.1 and earlier) issued by the Clinical Trial Coordination Group (CTCG). Here's what we recommend:
- Keep it lay-friendly: The LPS is intended for a broad audience, including those without a scientific background. To achieve this, it should follow the same principles as the lay summary of study results, as outlined by the GLSP. These principles have been endorsed by the European Commission and integrated into EudraLex Vol. 10.3.
- Focus on what matters: The LPS should only include information that is relevant and understandable for a lay audience. Highly technical content, such as exhaustive lists of secondary endpoints, should be avoided in favor of clear, high level explanations that support understanding of the study’s purpose and design.
- Enhance section guidance: Current guidance in the Q&A is often sparse and unbalanced. We recommend incorporating best practices for lay-friendly communication to ensure clarity and consistency across all sections.
- Clarify key aspects: The LPS should be available in all the languages of the participating countries to ensure inclusivity.
- Leverage visuals: Graphics are a powerful tool for summarizing complex information, such as trial design. The guidance should encourage their use to make the LPS more engaging and accessible.
We want to develop recommendations for the writing of LPS that ensure that the information is truly accessible to everyone—specialists and non-specialists alike. Let’s work together to make clinical trials more inclusive!