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Plain Language Summary Requirements for Clinical Trials

Plain Language Summary Requirements for Clinical Trials

Plain language summaries (PLS) of Clinical Trial Results are a critical tool in medical communication to help disseminate summarized, easy-to-digest research information to general audiences. Typically, these are used to share details of clinical study protocols, publications, or results while eliminating much of the technical language and jargon that can create barriers to effective communication with the public.

Having a clear understanding of how certain studies or research might impact specific individuals or communities helps to demystify complex concepts, which can often spur mistrust or misunderstandings between researchers and the general public.

Alongside the rollout of the COVID-19 vaccines, PLSs have been essential in bridging existing knowledge gaps. They’ve demonstrated the efficacy and safety of individual vaccines to catalyze comprehension and, ultimately, vaccine uptake. With this in mind, here are our key insights into developing an effective PLS. 

Develop a PLS with the General Public in Mind

The average person has the health literacy of a US 8th grader (About a 12-year-old’s reading level), while much health information is communicated at a 10th-grade level or higher. This can limit patient engagement and recruitment during clinical research studies, as well as impact treatment adherence which leads to poorer health outcomes down the line. To mitigate these risks, it is important to develop a PLS that targets groups that don’t have the same level of understanding as medical professionals, scientists, or adults with high health literacy.

Be Consistent Across Documents

When working with different study designs, endpoints, and therapeutic areas, it’s important that documents remain consistent across the board. Develop the layout and content for each section using consistent style, language, and literacy level within programs. Use a style guide to conduct quality control and assess brand consistencies accordingly. 

Keep it Brief and Unbiased

Patients are looking for vital information and may be deterred or overwhelmed by superfluous information. It’s important to focus on clear, factual information in as few words as possible, with little to no jargon or technical language. Furthermore, the text should remain unbiased, be comprehensive, and avoid any promotional information, regardless of the study outcome. 

Understand the Regulatory Landscape

Regulatory requirements and guidelines are rapidly evolving, and they hold researchers to different standards depending on the region where they’re distributing the PLS. For example, under the EU CTR 536/2014, all Phase 1-4 interventional trials conducted within the EU are required to develop and submit a PLS of clinical trial results. Upon the EU CTR entering full enforcement, sponsors will be required to submit the PLS to the EU Clinical Trials Information System (CTIS) within 12 months of the conclusion of a trial or within six months for pediatric trials.

Additionally, industry indicators suggest that other national regulatory authorities, such as Health Canada and the US Food and Drug Administration, are gradually moving toward requiring a PLS for clinical trial results. In this case, it’s critical to begin developing your PLS strategy early on to remain compliant with shifting regulatory requirements.

Seek Expertise

Organizing a team to build and refine your PLS can ensure you are communicating the essential information in language easily understood by the target audience, all while complying with relevant regulatory requirements. Partnering with a vendor with expertise and in-depth PLS experience supporting sponsors and research teams sets you and your end-users up for success.

Want to discover how TransPerfect Life Sciences can help kickstart your PLS strategy? Download our checklist for a successful development process, or reach out to us to learn more.