Requirements for plain language summaries of clinical trials

Plain language summaries (PLS) are an important tool in medical communication that helps disseminate easily understandable research information to the general public. Typically, these summaries are used to share detailed information about clinical research protocols, publications, or results while eliminating many of the technical terms and jargon that can create barriers to effective communication to the public.

Having a clear understanding of how a particular study affects an individual or community can help demystify complex concepts, thereby reducing misunderstanding or mistrust between researchers and the public.

With the introduction of COVID-19 vaccines, PLSs have played a vital role in filling existing knowledge gaps. They demonstrate the effectiveness and safety of various vaccines, promote people's understanding of vaccines, and ultimately increase vaccination rates. Against this background, the following are our key insights on developing effective PLSs.

Developing PLS with the public at the center

The general population's health literacy is equivalent to that of an eighth-grade student in the United States (about the reading level of a 12-year-old child), but much health information is communicated at a tenth-grade level or higher. This may limit patients' enthusiasm for participating in clinical research and affect treatment compliance, leading to poor health outcomes. To reduce these risks, it is particularly important to develop PLSs for groups with low health literacy and ensure that they are easy to understand.

Maintain file consistency

It is important to ensure consistency in your documentation when dealing with different study designs, endpoints, and therapeutic areas. Use a consistent style, language, and reading level to design the layout and content of each section across projects. Utilize a style guide for quality control and assess brand consistency accordingly.

Be concise and objective

Patients need to get key information but may be confused or overwhelmed by redundant information. Therefore, it is important to focus on the most concise and accurate information, avoiding jargon or technical language. In addition, the text should remain objective and comprehensive, avoiding any promotional information, regardless of the research results.

Understanding the regulatory environment

Regulatory requirements and guidelines are evolving rapidly, and different regions have different standards for investigators. For example, under the EU Clinical Trials Regulation (EU CTR 536/2014), all Phase 1-4 interventional trials conducted in the EU are required to develop and submit a PLS of clinical trial results. Once the EU Clinical Trials Regulation is fully effective, sponsors must submit the PLS to the EU Clinical Trials Information System (CTIS) within 12 months of the end of the trial, or within 6 months of the end of pediatric trials.

In addition, industry information indicates that other national regulatory agencies, such as Health Canada and the U.S. Food and Drug Administration, are also moving toward requiring PLS for clinical trial results. In this context, it is critical to develop a PLS strategy early to comply with evolving regulatory requirements.

Seek professional support

Organizing a team to build and improve a PLS ensures that you convey important information in a language that is easy for your target audience to understand while complying with relevant regulatory requirements. Partnering with a vendor with expertise and experience in the PLS field will lay the foundation for success for you and your end users.

Want to learn how Arrow Translation can help you kick-start your PLS strategy? Download our checklist for successful development, or contact us for more information.

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