Clinical trial findings should be understandable to everyone, especially the patients who participate in the research. However, many trial documents are written for regulators and healthcare professionals, making them difficult for the public to interpret.
As transparency and patient engagement become central to clinical research, organizations are increasingly expected to communicate study information in clear, accessible language. A well-written plain language summary supports these efforts by helping participants and the public understand the purpose, results, and impact of clinical research.
This guide explains what a plain language summary is, outlines the principles of effective writing, and shares best practices for creating clear, accurate, and patient-friendly clinical trial communications.
What Is a Plain Language Summary?
A plain language summary (PLS) is a clear, non-technical overview of a clinical trial and its results. It explains complex medical information in language that people without scientific or medical training can understand.
Who Is It Written For?
Unlike clinical study reports or scientific publications, which are written for regulators and researchers, a plain language summary is designed for patients, caregivers, trial participants, advocacy groups, and the general public. Its purpose is to make clinical research more transparent and accessible.
A well-written PLS answers the questions readers are most likely to ask, including:
- Why was the study conducted?
- Who participated in the trial?
- What treatment or intervention was studied?
- What were the main findings?
- Were there any risks or side effects?
- What do the results mean for patients or future research?
To achieve this, the summary should use simple, everyday language while remaining scientifically accurate. Technical terms should be avoided where possible or explained in plain language when they are necessary.
Unlike promotional materials, a PLS presents balanced, evidence-based information without overstating benefits or minimizing risks. The goal is to improve understanding, support informed decision-making, and build trust between researchers and the communities they serve.
As patient engagement becomes a greater priority, plain language summaries are also gaining regulatory importance. For example, the European Union’s Clinical Trials Regulation (EU CTR No 536/2014) requires sponsors to provide plain language summaries of clinical trial results, while ClinicalTrials.gov offers guidance on writing clear and accessible study summaries. Together, these developments reinforce the importance of communicating clinical trial results in language patients and the public can understand.
Key Principles of Writing Plain Language Summaries
Writing an effective plain language summary involves more than simplifying medical terms. It requires presenting accurate information in a way that is easy for patients and the public to understand. The following principles can help ensure your summary is both accessible and scientifically accurate.
1. Use Simple, Everyday Language
Replace technical terms with familiar words whenever possible. For example, use “high blood pressure” instead of “hypertension” or “side effects” instead of “adverse events.” If a medical term is essential, explain it in plain language.
2. Keep Sentences Short and Direct
Present one idea at a time using clear, active language. Short sentences are easier to read and help readers understand complex information more quickly.
3. Avoid Jargon and Unnecessary Acronyms
Minimize medical jargon and abbreviations. If an acronym or technical term cannot be avoided, spell it out and explain it the first time it appears.
4. Explain Technical Concepts Clearly
Some clinical terms, such as “placebo” or “randomized,” may be necessary. Define them in simple, conversational language so readers can understand their meaning without prior medical knowledge.
5. Focus on the Reader
Organize the summary around the questions patients are most likely to ask, such as:
- Why was the study conducted?
- What happened during the trial?
- What were the main results?
- Were there any risks or side effects?
- What do the findings mean?
6. Maintain Accuracy and Balance
Keep the summary clear without oversimplifying the science or changing the meaning of the study findings. Present the findings objectively, accurately describe both benefits and risks, and ensure the content remains consistent with approved clinical trial documents.
Best Practices for Writing Clinical Trial Summaries
A high-quality plain language summary should be clear, accurate, and easy to understand. These best practices can help ensure patient-friendly communication without compromising scientific integrity.
1. Follow a Clear Structure
Organize the summary in a logical order so readers can quickly find the information they need. Include:
- Study purpose: Why the trial was conducted.
- Study design: Who participated and what was evaluated.
- Key findings: The main results explained in plain language.
- Safety information: Important side effects or risks presented objectively.
- What the results mean: How the findings may inform future research or patient care.
2. Use Patient-Friendly Formatting
A well-structured document is easier to read and understand. Improve readability by:
- Using clear headings and subheadings
- Breaking up long paragraphs
- Using bullet points where appropriate
- Including simple tables or visuals to explain complex information
Accessibility should also be considered. Documents should be easy to read on both desktop and mobile devices, with sufficient white space and readable fonts.
3. Review and Validate the Content
Before publication, review the summary to ensure it is scientifically accurate, compliant, and easy to understand. The review process may involve medical experts, medical writers, regulatory teams, and patient representatives to verify that the content accurately reflects approved study documentation while remaining accessible to patients and the public.
The summary should also be updated whenever study results or safety information change to ensure readers continue to receive accurate and current information throughout the clinical trial lifecycle.
4. Consider Translation and Localization for Global Clinical Trials
For multinational clinical trials, a clear English summary is only the first step. Patient-facing content should be professionally translated and localized to reflect local language, culture, and regulatory requirements while preserving scientific accuracy. A direct translation may not always convey the intended meaning, particularly when medical terminology, cultural context, or health literacy levels differ across regions.
Working with experienced providers of clinical trials translation services helps ensure multilingual summaries remain clear, compliant, and culturally appropriate while maintaining consistency with the original clinical trial information.
Conclusion
A well-written plain language summary helps make clinical trial results more accessible, strengthens patient trust, and supports greater transparency in clinical research. For global studies, professional translation and localization ensure these summaries remain accurate, culturally appropriate, and easy to understand across languages and regions.
At EC Innovations, we help pharmaceutical companies, biotechnology organizations, and CROs develop compliant, patient-centered clinical trial communications through expert translation and localization services. Whether you need multilingual plain language summaries or other patient-facing clinical content, our life sciences specialists can help you communicate with clarity, accuracy, and confidence across global markets. Contact us to learn how we can help your next clinical trial reach audiences with clarity and confidence.
