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Road map to successful layperson summaries under the CTR
Plain language can be a complex matter, writes Pia Windelov, senior director, regulated solutions portfolio, at Lionbridge Life Sciences.
sponsors to produce summaries of clinical trial results for laypersons. Annex V of the Clinical Trial Regulation (CTR) describes the regulatory required content of these summaries and includes 10 mandatory information elements. Recently, a Good Lay Summary Practice (GLSP) guidance was developed under the leadership of the European Forum for Good Clinical Practice (EFGCP) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). On 4 October, this guidance was released under EudraLex, Volume 10, as a clinical trials guidance adopted by the Clinical Trials Expert Group under the European Commission. The purpose of the GLSP is to offer recommendations on how to prepare, write, translate and disseminate layperson summaries to trial volunteers and the general public. As a practical handbook, which also includes a Quick Guide, the intention of the GLSP initiative has been to help trial sponsors produce objective, engaging, understandable plain-language summaries with a focus on fair access to trial results and patient involvement. Lionbridge has been an active contributor to the GLSP and, in this article, we highlight some of our recommendations on language and translation aspects of layperson summaries.
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Plan and control your translation workflows Despite the crucial role of language as a vehicle for clear and accurate communication in multinational clinical trials, translations are often a last-minute undertaking managed by clinical operations. Such a ‘just-in-time’ approach may work for industry trial sponsors that have engaged one or more qualified language service provider(s) to translate their essential clinical trial documentation. However, the sensitive nature of
66 | Outsourcing in Clinical Trials Handbook
tarting January 2022, the European Clinical Trial Regulation (Regulation (EU) No 536/2014) will apply and require trial
publicly disclosing research results and the tight regulatory timelines for the delivery of layperson summaries call for more proactive planning and control of translation workflows. Efforts spent planning the development and translation of the summaries will benefit both the quality and timely delivery of the summaries. During Lionbridge’s involvement in the
development of the GLSP, it has become clear that results disclosure in plain language comes with multiple communication concerns: • How do sponsors ensure that trial results are presented at the literacy levels of the target audience and understandable for the general public at the age of 12?
• How can end points and outcomes be objectively selected and presented in summary format without ‘cherry-picking’?
• How can secondary patient-relevant end points be presented without putting undue emphasis on results that are not powered for statistically valid conclusions?
• When and how can patients or layperson representatives be involved in testing the readability of the summary?
• How does the sponsor ensure clear, engaging and empowering language in source as well as in target languages? The GLSP has been a long-term successful
collaboration across the pharmaceutical industry, academia, not-for-profit organisations and patient organisations. In their discussions, they have brought up these and many other questions, and Lionbridge has contributed recommendations for a step-by-step translation workflow.
Language requirements under the CTR The CTR does not spell out a legal requirement for translating the layperson summary into local language. Per definition, language requirements in the EU are a member state matter determined by national competent authorities. Looking
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