Providing lay summaries in plain language is a global trend to facilitate comprehension and transparency around clinical trial results. Since the EU Clinical Trial Regulation (CTR) 536/2014 requirement took full effect in January 2022, EU sponsors must provide lay summaries for all clinical trials (CT), regardless of phase or outcome. In the US, the FDA has been considering a similar initiative. And a growing number of scientific journals now expect or encourage jargon-free summaries of research articles for lay audiences. 

These summaries provide benefits that range from improved accessibility, enhanced inclusion, and improved patient safety to more informed decision-making. But what happens when these documents require translation into multiple languages and variants? Why is partnering with an experienced, specialized language service provider (LSP) crucial to ensure successful dissemination across languages and cultures? 

Reviewing the Basics: What are Lay Summaries (LS)?

As the name indicates, Lay Summaries summarize the results of clinical trials in a way that patients and the general public can easily understand, in a sense “translating” complex scientific content into reader-friendly language. They use plain language and appropriate principles of numeracy and design to provide consumer-friendly information on the objectives and the design of clinical trials. In addition, these documents explain risks, benefits, study endpoints, key findings, and outcomes. Lay Summaries are indispensable tools for patient and caregiver communication that enhance transparency and comprehension. Well-crafted summaries bridge the gap between scientific rigor and patient understanding, benefiting the research community and the public.

What about PLS and PLS-P?

Although there is some overlap in terminology, Lay Summaries (LS), Plain Language Summaries (PLS), and Plain Language Summaries for Publications (PLS-P) are distinct concepts.

Plain Language Summaries (PLS)

PLS can refer to two things. On the one hand, this is the term often used in the US to refer to LS, for example, when discussing whether the FDA plans to follow in the footsteps of the EMA and require these summaries for clinical trials. In terms of academic publications, the term refers to a summary in non-technical language, often around 250-300 words in length, submitted along with an academic abstract of a research article for publication, sometimes called a “lay abstract.”

Plain Language Summaries for Publications (PLS-P)

PLS-Ps are more extended forms of PLS in the context of peer-reviewed journals that fully summarize a published article in approachable, non-technical language. A PLS-P often includes images and illustrations and may be published in an infographic style, alongside the corresponding article, or as a standalone publication. 

EU CTR Lay Summaries: Enhancing Transparency and Accessibility

While it fits the Patient-focused drug development initiative of the FDA, that authority has not yet taken steps to require clinical study results to be provided in plain language. The EMA has taken a different tack: The EU CTR explicitly stipulates that LS be provided and uploaded to the newly created Clinical Trials Information System (CTIS) for all beginning clinical trials. By January 31, 2025, ongoing trials must also have been transferred to CTIS.

Disseminating and publishing Lay Summaries on the CTIS supports several key objectives:

Patient safety and empowerment:

• Lay Summaries allow patients, families, and caregivers to access information about CT in a language and format they can understand.
• Lay Summaries empower patients to understand the potential risks, benefits, and outcomes of CTs.

Informed decision-making:

• Lay Summaries give patients and caregivers access to the information they need to make better decisions regarding their health, including participation in clinical trials.

Accessibility and inclusivity:

• Lay Summaries ensure that the results of CTs are accessible to the broadest possible audience – not only patients and caregivers but also the general public.
• Lay Summaries promote inclusivity by breaking down barriers relating to complex terminology, technical jargon, and literacy.

It is only logical that providing fair and equitable access to this content requires making it available in the native language of a given patient. 

Language Access and Translation

According to Good Lay Summary Practice (GLSP), at a minimum, LS should be made available in the official local language or languages of each country where a trial was conducted. These languages should match those used in Patient Information Sheets (PIS) and Informed Consent Forms (ICF). If not authored in English, preparing an English version should also be considered to enhance accessibility throughout the EU and worldwide. GLSP also stipulates that these translated versions be provided as early as possible – ideally in parallel to the release of the original LS to ensure fair access to information for patients and the general public.

When conducting multi-country trials, translation is an integral part of the process that requires careful planning. Care must be taken to ensure that the meaning of the source document is preserved and that the cultural validity of the language is taken into account. In addition, the non-promotional nature of the LS must be maintained.

To see why this is such a vital part of successfully conducting a clinical trial across locales, it helps to have an idea of the complexity of two processes: LS development and translation.

The Lay Summary Process Explained

As per the GLSP Handbook, LS development consists of four key steps: