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Plain Language Summaries of Clinical Trial Results: What You Need to Know

The Nuts and Bolts of the EU's New Regulation

Plain language summaries, which provide a patient- and public-friendly summary of clinical trial results, are not new to clinical investigations. But a recent push for transparency and ethical disclosure of research results in the medical community has catapulted these documents into the spotlight.

 

In the EU, an upcoming Clinical Trial regulation makes mandatory the provision of plain language summaries by all sponsors in the European Union conducting:


  • Interventional (including low-interventional) clinical trials

  • Phase 1 to Phase 4 trials that take place in at least one site in the EU region

 

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Under the new regulation, the European Commission will establish a publicly-accessible EU database to ensure a sufficient level of transparency within clinical research and grant the public access to relevant information on clinical trials, including plain language summaries of clinical trial results. This legal enforcement now requires clinical trial sponsors to develop standard internal processes and to dedicate resources to clinical trial disclosure activities.

Why Plain Language Summaries are Necessary


General consensus suggests that disclosing research results to public audiences in plain language is necessary for three important reasons:


  1. To increase health literacy of the general population

  2. To increase public willingness to participate in and engage with clinical trials

  3. To spur the development of new research strategies


Additionally, patients can be valuable sources of information to researchers striving to understand the effects of a disease on a patient's life, design protocol procedures, or ensure the readability and usability of labeling and product information. Communicating to a global population through a plain language summary broadens a researcher's ability to gain important insights and allows more patients to benefit from the research.

 

While the EU has taken an early lead in regulating the disclosure of clinical research results in plain language, other countries and regions are expected to follow suit.

How Can You Create Effective Plain Language Summaries?

As a scientist newly tasked with creating these plain language summaries, how can you ensure you communicate your science story to the general public effectively, cost-efficiently, and in their native language?

It's an important and complex task, and Lionbridge can help.

Interested in learning how to author and translate plain language summaries successfully? Download our whitepaper for our tips.

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