The future of medical science depends on transparency: Why plain language summaries matter

In this blog, we explore the industry’s response to this new era of clinical trial transparency, why it’s fundamental to the future of medical science, and how the nuances of public awareness can be quite complex.

Why public trust is vital to the speed of medical research and innovation

Public trust is the cornerstone of medical research. Without it, pharmaceutical sponsors contend with public scepticism, leading to reduced trial enrolment and even reluctance to adopt new medical innovations. This lack of trust compromises timely release of new treatments and advancements in medical science.

The COVID-19 pandemic provides recent evidence that clear communication matters.

Multiple factors enabled significant velocity behind the COVID-19 vaccine journey of new medicine to market. The list included: open data sharing, regulators adopting rolling data submittals, and emergency use authorisations. Of vital importance, it also included high volunteer participation, which enabled the clinical trial to be conducted at unprecedented speed. Driven by public understanding of the trial and its intended output, volunteers put themselves forward for trial participation. This resulted in clinical trial completion in just a matter of months, significantly reducing time-to-market timelines.

While not all enablers utilised during the COVID-19 pandemic can be adopted for every new emerging medicine, the power of public knowledge can be applied to accelerate trial timelines. To enable this, regulatory authorities and sponsors alike are prioritising transparency in future clinical trial strategies. One significant development in this direction is the adoption of plain language summaries.

Public trust through awareness

Plain Language Summaries (PLS), also referred to as lay summaries, aim to empower patients, caregivers and the public by providing a clear nonbiased explanation of clinical trials and their factual outcomes. This access and understanding contribute to inclusivity and foster trust in medical research. To do this, PLS transform technical trial results into public-friendly language that is freely accessible to the public. Typically, a PLS will include explanations of:

The trial’s purpose and objective
The trial’s design and methods
The treatment or intervention being tested
The trial’s results and findings
The product side effects and risks
Where to locate further information

The foundation of PLS lies in the European Union Clinical Trial Regulation (EUCTR 536/2014). This was introduced to improve transparency and accessibility in clinical trials across the European Union (EU) and became effective January 2022. EUCTR mandates the submittal of PLS to the public 12 months after trial completion (six months for paediatric trials) alongside the traditional trial documentation. It aims to:

Enhance public understanding of clinical trials
Increase trust in the pharmaceutical and clinical research industries
Ensure participants and their families can access trial results in a meaningful way

So effective, adoption is expanding

There has been a rise in PLS availability each year. Many sponsors voluntarily created PLS prior to the EUCTR directive effective date, and trials that are subject to EUCTR have resulted in increased PLS availability. A secondary avenue behind increasing adoption volumes is through adoption expansion. While the EUCTR-mandated change impacted all EU member states and markets under the European Economic Area agreement, other markets have recognised the value of PLS. As a result, other markets have introduced their own regulations and guidelines, including Turkey, Moldova, Ukraine, Switzerland and the United Kingdom.

Are PLS really making a difference in public trust?

Research has shown that deploying PLS significantly enhance public trust and contribute to increased participation in trials. A survey conducted by the European Patients Academy (EUPATI) revealed that 70% of responders felt more confident in the pharmaceutical industry when trial results were communicated in plain language. This transparency not only strengthens the credibility of the sponsor but also positively impacts recruitment. A 2021 report by the Centre for Information and Study on Clinical Research (CISCRP) found that individuals with access to understandable information on a clinical trial were 50% more likely to consider participation in future trials. By demystifying complex medical information, PLS empower patients and the public, increasing their willingness and motivation to engage in clinical research.

The complexities behind PLS

While the concept and language of PLS may seem straightforward, the process of creating them is not.

Complexities start at the authoring stage. PLS must provide accurate and detailed information while avoiding technical jargon or promotional tone, and the language used must be accessible for readers with varying levels of health literacy. As a result, authors must adhere to strict regulatory guidelines while crafting content that resonates with a non-specialist audience. Striking this balance requires a deep understanding of both clinical trial data and the ability to distil complex findings into digestible and engaging content.
Complexities increase with each additional local language translation. Unlike standard technical or scientific translations, the translation stage for PLS must be completed without increasing the grammatic or linguistic complexity. Therefore, as well as the translation needing to be linguistically accurate, relatable, and understandable within the target language context, it must also align to a defined reading level. In addition, quality output is vital. Translation errors can distort the meaning of the trial results and thereby undermine the public trust sponsors are aiming to achieve. Specialised expertise and rigorous quality assurance are essential to ensure the final product is accurate, culturally appropriate and aligned with global and local requirements.

Comprehensive solutions for PLS

ICON is a trusted partner for delivering high-quality, compliant and audience focused PLS.

Our in-house PLS authoring and translation specialists provide expertise both as individual services and as part of a fully integrated execution model. By combining the knowledge of ICON Medical Writing and ICON Language Services, we offer a seamless, streamlined execution model which adheres to all regulation guidance. Our service simplifies workflows, enhances quality and accelerates delivery of submission-ready summaries.

Our approach leverages the strengths of ICON experts to provide:

Expert authoring: ICON’s medical writers craft clear, accurate and regulatory‑compliant PLS. Complex clinical trials are distilled into patient‑friendly language while still maintaining scientific integrity.
Cultural adaptation through translation: Once authored, PLS are translated into local language by ICON’s certified linguistic experts.

The benefits of a unified workflow:

Streamlined processes: Reduces the handoffs and wait times which are typical in a multiple-vendor PLS resource model.
Consistent output: Harmonised authoring and translation maintain a consistent voice and message in every language.

Submission-ready output: Delivering high quality, ready to launch summaries that meet global regulatory requirements and resonate with local public audiences. ICON’s integrated service model ensures you benefit from a single, cohesive service capable of delivering exceptional PLS. This helps you foster transparency, meet compliance requirements and build trust with patients, caregivers and the public. By crafting PLS clinical researchers can improve public understanding for effective medical research and clinical trials.

Contact us today to learn how our integrated services can simplify your workflows, meet your regulatory needs and deliver impactful PLS.