New guide to clinical trial lay summaries available for EU sponsors

Regulatory NewsRegulatory News | 05 October 2021 |  By 

The European Commission (EC) has laid out recommendations on best practices for preparation, translation and dissemination of lay summaries of clinical trial information, intended both for trial participants and the general public, in a newly published document.
The EC’s Clinical Trials Expert Group (CTEG) adopted the guidelines in July 2021; the 85-page document walks users through the lay summary (LS) process from the planning and scoping stage, through the development process, to the necessary steps for testing translations of the LS, to the final dissemination stage.
The lay summary gives sponsors a framework to fulfill their legal commitments under EU Regulation 536/2014 Article 37, which requires them to file lay summaries of all pharmaceutical trials into the Clinical Trials Information System (CTIS).
The new document provides a quick guide as well as a complete Good Lay Summary Practice (GLSP) handbook. Going beyond a cookbook approach, the guideline gives recommendations for “how to enable patient engagement all through the LS process,” although the document also acknowledges that patient engagement can be a challenge, depending on the resources and infrastructure a sponsor has available.
Pediatric trials are also called out in the GLSP plan, which recognizes that these studies need special approaches for LS generation; limited data to date on best practices for pediatric trial lay summaries also limits recommendations in the GLSP document.
The general aim for LS processes is “to enable all sponsors to generate and disseminate objective and understandable information on clinical trial results,” so trial participants and the general public alike can have access to high-quality, understandable information.
Sponsors are advised to develop a standard operating procedure and a template for LS communications as part of the planning process; sponsors should plan to document approval of the LS before locking the content and entering it into the EU portal.
The GLSP lays out the key elements of a clinical trial LS, including clinical trial identification, the name and contact details for the sponsor, general information about trial design, and a description of the trial population. Further elements include the investigational products used and anticipated adverse reactions, the results anticipated from the trial stated as a LS of primary endpoints, and further comments on the outcome. Finally, the LS should state whether follow-up trials are anticipated, and where to find further information about the trial or the investigational product.
The GLSP devotes several pages to outlining the skills required for development of a good LS, the linguistic differences between scientific and lay communication, and general principles of plain language as applied to communication aimed at individuals with low health literacy. Specific examples and a “dos and don’ts” list are provided.
Sponsors preparing a LS for a clinical trial must be particularly careful in how they communicate risk, bearing in mind that “certain trial designs will have additional specific requirements.” The GLSP notes that when solicited and unsolicited adverse events are collected in a trial, this difference may require a more detailed explanation in the LS.
The GLSP sets forth layout, graphics and typography considerations that contribute to easy readability and increased understanding of the content of the LS.
Although translation is not required by the EU Clinical Trials Regulation (CTR), the clinical trials expert group that developed the GLSP recommends that, at a minimum, “the LS should be provided in the local language(s) of each of the countries where the trial took place.
Dissemination beyond filing the LS into the CTIS should include a mix of technical methods, such as email and posting on the sponsor’s website, and non-technical methods such as using printed copies to provide to trial participants.
The GLSP includes a number of potential barriers to effective distribution of the PSLG, such as bounced emails or even lack of email access and provides potential solutions.
Appended to the document is a series of reference tables that cover such topics as lay language examples for common phrases used in describing clinical trials, suggested steps for user testing of LS documents, developmental considerations for pediatric LS, a step-by-step translation guide, and summaries of issues to consider in dissemination.
A second appendix provides a list of glossaries that may be used in developing LS.
Communication of patient-level data and lay summaries of scientific publications such as journal articles and conference abstracts lie outside the scope of the guidance.
 Good Lay Summary Practices


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