Language barriers in clinical trials: an interview with Sofia Bertling

Bridging communication gaps to improve patient participation and trial outcomes.

2025-03-17

Blog

Clinical trials are essential for advancing medical research and bringing innovative treatments to market. However, one major challenge for patient recruitment, retention, and overall trial success, that we’ve previously written about, is the presence of language barriers. 

To shed light on this critical issue, we spoke with Sofia Bertling, a seasoned professional with over 25 years in the MedTech industry. As CEO and one of the founders of Utilizer (a company dedicated to revolutionizing bacterial diagnostics), as well as a board member for organizations like Care to Translate, she has firsthand experience addressing language-related challenges in clinical research.

Understanding the impact of language barriers in clinical trials

Sofia has been deeply involved in life sciences and clinical research since 2006. From planning trials to overseeing large-scale treatment initiatives, she has witnessed the direct consequences of language barriers on patient participation.

“When patients are approached to participate in a trial, they need to feel fully informed and secure about what their involvement entails,” she explains. “If there’s any uncertainty about their safety or data privacy due to miscommunication, there’s a high risk they’ll decline participation or drop out later. This not only results in lost time and money but can also compromise the validity of trial data. It will also extend the recruitment period for your study if you are unable to attract all eligible patients with the required indication.”

The role of language in patient recruitment

One of the biggest hurdles in clinical trial recruitment is ensuring that all eligible patients, regardless of their native language, fully understand the study’s purpose, procedures, and potential risks. “If patients don’t understand the information provided, they simply won’t participate,” Sofia states. “Medical communication must be clear, respectful, and culturally appropriate to encourage engagement.”

Beyond consent forms, language barriers affect all stages of the clinical trial process. From initial screenings to follow-up appointments, miscommunication can lead to incomplete data collection, incorrect patient responses, and even ethical concerns regarding informed consent.

Real-world challenges: an anecdote from the field

Sofia recalls a striking example from a clinical trial involving urinary tract infections. “A Persian-speaking patient was visibly confused, wandering around the primary care corridor with his urine sample, unsure where to go,” she recounts. “I managed to guide him to the bathroom by physically leading him there. At the time we only had Swedish and English study information sheets and neither was understandable for him. We tried to use Google Translate to communicate trial details, but in the end, he was hesitant to participate. We are still unsure if our translation conveyed the right message.”

Translation to more languages was later done which increased the attendance rate and diversity of participants. But this case highlights how inadequate translation tools can create barriers instead of breaking them, reinforcing the need for better language solutions in clinical research.

How language barriers impact clinical trial outcomes

When patients struggle to understand trial information, it leads to several negative consequences:

  • Lower diversity in patient populations: Trials may not accurately reflect real-world demographics, limiting the generalizability of results.
  • Slower recruitment times: Delays in reaching target participant numbers prolong the research process and delay potential medical advancements.
  • Higher dropout rates: Patients who feel uncertain or uninformed are more likely to discontinue participation, reducing data reliability.

The role of technology in overcoming language barriers

Innovative solutions like Care to Translate are helping bridge these communication gaps. “By enabling physicians and patients to communicate in their native languages, tools like this foster trust and understanding,” Sofia explains. “This not only improves patient recruitment but also ensures that trial data is as accurate and comprehensive as possible.”

Ultimately, addressing language barriers in clinical trials is about more than just improving logistics - it’s about ensuring that medical advancements benefit all patient populations, regardless of language or background.

Interested in learning more?

Book a demo to explore how your company can use Care to Translate to communicate with all participants during clinical trials.