The Evolving Role of Medical Writers in ePI

For years, the information that comes with medicines has lived on paper. Although practical, it is often hard to read, easy to lose, and creates waste. Today, that same information is shifting to the digital realm. Electronic Product Information or simply “ePI”—helps make medicinal information more understandable, easier to access, and environmentally conscious. This shift also reflects how people already look for health information; according to CISCRP’s 2025 Perceptions & Insights Study, 58% of people first hear about clinical research opportunities online. 

As ePI emerges as a potential best practice, medical writers have a bigger role to play than ever. Writers are the ones who make sure the science stays accurate while the language stays human. In other words, medical writers are the bridge between data and understanding, helping ensure that ePI serves the people it’s meant to reach.

From Access to Understanding

In recent years, there has been a push for “open access” to scientific information. For the pharmaceutical industry, this means that certain clinical trial data is no longer hidden behind journals and paywalls but is freely accessible to everyone. This is a fantastic step in the right direction. However, access alone isn’t enough; people also need to understand what they are reading.  

This is where medical writers come in. By translating technical jargon into accessible content, medical writers act as the crucial link between the industry and the public. At CISCRP, this work takes many forms and includes:

• Lay Summaries of the Protocol Synopsis (PS): Provide a short 2–page summary of a study’s designed and planned analyses.  
• Trial result summary (TRS): Explains study findings in plain language. 
• Plain language summaries of publications (PLSP): Similar to a TRS, but provides more in–depth information and made to accompany journal publications.
• Brochures, and infographics: A highly flexible format that can explain complex topics, such as informed consent, in easy-to-read chunks.

These materials are digital and publicly accessible, and so, they model a key goal of ePI: a more connected and transparent health information ecosystem. 

Making Information Work for Everyone

True accessibility means that information is easily understood by everyone who reads it. Health information should be clear and usable whether someone is a healthcare professional, a caregiver, or a patient reading about their medicine for the first time. To accomplish this, medical writers must consider numerous things when creating content, such as:  

• Average reading levels of the community they are trying to reach
• Cultural contexts, age, gender, and health history of individuals
• Diversity of individuals’ learning styles
• Visual challenges such as color-blindness when creating graphical content
• Changes in language over time (including slang)

For example, a medical writer might adapt a clinical trial brochure for older adults by using familiar images, relatable examples, and language that feels natural to that community. Small choices like these help make sure ePI content speaks to people in a way that feels familiar and respectful. 

Creating Quality and Consistency 

As ePI continues to gain attention, it’s important that the information people see is accurate as well as consistent. Medical writers and medical editors help set those standards by creating practical guidelines for structure, tone, and readability. Clear headings, familiar wording, and consistent formatting make ePI easier to navigate.  

For instance, using a templated format for TRS that explains key terms, covers the findings of the study, and describes what they mean for patients, can help readers know what to expect and where to find certain details. 

These digital deliverables also support future integration into ePI systems. When TRSs, PLSPs, brochures, and infographics are created in digital, publicly accessible formats, they can be easily incorporated into an ePI platform. This can help people move quickly and easily between related information, such as trial results, safety details, or plain-language explanations of how a medicine or treatment works. 

The Role of AI 

Artificial intelligence is already changing how we create and manage health information. It can help with tedious tasks like brainstorming, organizing, and translating. AI can make our work faster and more efficient, but it needs to be used responsibly.   

Medical writers bring the human touch that technology can’t replace. An experienced writer understands the why behind the words. They can adapt the language to the right contexts, read and shift the tone and emotion, and balance accuracy with clarity. AI can follow patterns, but it can’t make ethical decisions or question why something should be said a certain way.  

Findings from CISCRP’s 2025 Perceptions & Insights Study show that while many people are open to AI being used to improve health communication, trust depends on two things: that humans remain involved in reviewing AI-generated content and that companies are transparent about how AI is used. In fact, 57% of respondents said it was very important for companies to clearly disclose when and how AI played a role.  When used wisely, AI can support the work of medical writers, helping them to focus on creating information that is accurate, clear, and human centered.

Looking Ahead

The future of ePI is still being written, and medical writers will play a key role in shaping it. Their work sits at the intersection of science, communication, and trust. By keeping these values at the center, ePI can give the public the confidence they need to make informed health care decisions. 

At its core, ePI is a way for medical writers to do what they’ve always done best—connect people with science that impacts their health. 

How do you see the role of medical writers evolving over the next decade?