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Clear Communication Is the Greatest Gift: Reducing Patient Burden in Clinical Trials 

Clear communication in clinical trials is one of the most effective yet underestimated ways to reduce patient burden. As the life sciences industry continues to prioritise patient-centricity, how information is communicated has a direct impact on patient understanding, trust, and ongoing engagement. 

This is particularly relevant in Europe, where clinical trials frequently span multiple countries, languages, and healthcare systems. According to the European Medicines Agency (EMA), over 60% of clinical trials conducted in the EU are multinational, increasing the complexity of patient communication and localisation requirements. In this context, clear communication in clinical trials is a must. 

Why Patient Burden Remains a Challenge in Clinical Trials 

Patient burden encompasses the physical, emotional, cognitive, and logistical demands placed on trial participants. Research published in Applied Clinical Trials indicates that nearly 30% of patients withdraw from clinical trials, with confusion, poor understanding, and communication challenges cited as key contributing factors. 

Common drivers of patient burden include: 

In Europe’s diverse research environment, direct translation alone often fails to address these issues, increasing the risk of misunderstanding and disengagement. 

Clear Communication in Clinical Trials: A Patient-Centric Imperative 

Clear communication in clinical trials is about enabling patients to make informed decisions and participate with confidence. This requires presenting scientifically accurate information in a way that is accessible, well-structured, and culturally appropriate

The World Health Organization (WHO) reports that almost half of European adults have limited health literacy, making it difficult for many patients to understand complex medical information without support. This reinforces the need for plain language, logical structure, and consistent messaging across all patient-facing content. 

European regulators increasingly recognise this, placing greater emphasis on transparency, dialogue, and patient understanding throughout the research process. The EMA has established a comprehensive framework for patient and consumer involvement across the medicines lifecycle, reflecting a long-standing commitment to the inclusion of patient experience in regulatory decision-making (European Medicines Agency – Patients and Consumers: https://www.ema.europa.eu/en/partners-networks/patients-consumers).

This focus is further reinforced by guidance from the European Patients’ Academy on Therapeutic Innovation, EUPATI. Their Toolbox outlines best practices for involving patients in regulatory processes and supports clear, patient-centred communication across clinical research (EUPATI guidance on patient involvement: https://toolbox.eupati.eu/resources/patient-toolbox/guidance-for-patient-involvement-in-regulatory-processes/).

From Compliance to Comprehension: Improving Patient-Facing Trial Materials 

Patient materials such as informed consent forms, patient diaries, recruitment content, and visit instructions are often written to satisfy regulatory requirements first. While compliance is essential, comprehension must follow. 

Evidence demonstrates that simplifying consent forms and providing well-structured, plain-language information significantly improves patient comprehension of study procedures, risks, and benefits (PubMed study). By prioritising clarity and cultural appropriateness, sponsors and research organisations can reduce patient burden, build trust, and support engagement across multinational trials.

Improving comprehension requires: 

This approach supports both regulatory review and patient engagement, particularly in multinational European trials. 

Reducing Cognitive Load Through Thoughtful Language 

Research grounded in cognitive load theory indicates that reducing unnecessary cognitive burden improves task performance and adherence to clinical procedures in healthcare contexts. For example, studies have shown that higher cognitive load is associated with lower guideline adherence among clinicians, highlighting the importance of presenting information in a way that minimises mental effort and supports comprehension. In clinical research, this translates into better protocol compliance and data quality.

Clear communication reduces cognitive load by: 

The Role of Language and Localisation in European Clinical Trials 

Europe’s linguistic diversity presents unique challenges for sponsors and CROs. Effective localisation ensures that patient materials resonate with local populations while maintaining consistency across the study. 

Successful localisation considers: 

This approach supports inclusivity and helps ensure trials are accessible to a broader, more representative patient population. Avantpage Life Sciences enhances this process through specialised language and localisation services for clinical research, helping sponsors align global study design with local patient needs.

Trust, Transparency and Long-Term Impact 

Trust is the cornerstone of successful clinical research. The OECD’s Patient‑Reported Indicator Surveys (PaRIS) and related analyses emphasise the importance of trust in healthcare systems, showing that patient experience and quality of care are strongly linked to trust levels. Higher trust is associated with better perceptions of care and patient engagement. Lack of trust, on the contrary, remains one of the most significant barriers to clinical trial participation across Europe, especially among populations that are historically underrepresented or have limited exposure to medical research.

Building trust goes beyond simply sharing information; it requires clear, culturally sensitive, and patient-centred communication that fosters transparency and ensures participants feel respected, understood, and confident in the research process. By designing patient-facing materials that are accessible, well-structured, and culturally adapted, sponsors can directly support comprehension, reduce uncertainty, and strengthen patients’ confidence in the study.

When patients have a clear understanding of a study’s purpose, the procedures involved, and the potential risks and benefits, they are more likely to stay engaged throughout the trial, follow study protocols accurately, provide reliable and high-quality data, and consider participating in future research initiatives. Over time, this foundation of trust not only strengthens individual studies but also enhances the broader clinical research ecosystem, reinforcing the ethical integrity, sustainability, and credibility of programmes across diverse populations and multinational settings.

Clear Communication as a Strategic Advantage 

Beyond fulfilling an ethical responsibility, clear communication offers sponsors and research organisations a meaningful, competitive and operational advantage. Clear communication in clinical trials aligns patient needs with scientific and operational objectives, creating value across the entire trial lifecycle. 

Well-designed patient communication can: 

A Thoughtful Way Forward 

As the year draws to a close, reflecting on ways to reduce patient burden and strengthen engagement in clinical trials can provide valuable insights for improving participant experience. Clear, patient-centred communication not only supports better outcomes for participants but also enhances the overall quality and credibility of research programmes.

If you are exploring strategies to improve patient understanding and engagement, we invite you to connect with our team and discover tailored solutions. Explore our website to learn more about our global expertise in language solutions for life sciences.

From all of us at Avantpage, we wish you a joyful holiday season and a successful year ahead, and we look forward to supporting your patient-centric research initiatives in the year to come.