Under the EU Clinical Trial Regulation (CTR), the EU Medical Device Regulation (MDR), and the EU In Vitro Diagnostic device Regulation (IVDR), as well as ongoing initiatives of the US FDA, plain writing and plain language materials are either required or encouraged. As part of the CTR, plain language summaries of clinical trial results became required in the EU. In March 2024, the FDA published a draft industry guidance on Consent Information presented in plain language at a target population’s proficiency and educational level. This blog will offer guidance from our life sciences translation services team for plain language communication and tackling the challenges of translating scientific medical content, like clinical summaries, into plain language writing.

Tip 2: Adhere to Health Literacy and Good Lay Summary Practices for Plain Language Communication

There are no strict regulations on writing for a lay audience. However, following best practices such as Health Literacy and Numeracy Principles significantly improves the accessibility of information. Health Literacy principles emphasize using simple, everyday words, an active voice, and avoiding medical jargon. Health Numeracy principles guide the presentation of quantitative information. They suggest, for example, using whole numbers or visuals to aid understanding and avoid leaving calculations for the reader. Translating scientific or medical language into simple conversational language is a multidisciplinary task requiring subject matter expertise and linguistic skills. For further guidance, refer to the Good Lay Summary Practice guidance, published on EudraLex, Volume 10 - Clinical Trials Guidelines.

Tip 3: Test Your Source Language’s Readability for Better Plain Language Communication

There are varying approaches for readability testing, and solutions depend on specific needs, budget, and timelines for plain language communication initiatives. For some specific purposes, a user consultation may be necessary, e.g., for readability testing of Labeling and Package Leaflets submitted for regulatory marketing authorization of a new drug. In many other cases, technology offers readability test tools that are both cost- and time-efficient. Customers still use traditional readability formulas developed in the mid-20th century, such as the Flesch-Kincaid Grade Level score and the Gunning Fog Index. These tools can offer a basic gauge of readability, but should be applied cautiously, as they may not account for context or textual meaningfulness.