In the evolving landscape of clinical research, patient engagement has emerged as a cornerstone of successful clinical trials. In addition to improving recruitment and retention of patients, empowerment through education fosters patient understanding, trust, and compliance. This article explores a framework for patient education in clinical trials, highlighting the importance of understanding patient needs, developing targeted educational materials, and integrating content into trial platforms, and presents the resulting scientific and operational benefits.
1. Partnering with patients to reveal knowledge gaps
Patients often report a lack of information in clinical trials and express a clear need for better understanding.
Effective patient education begins with a thorough evaluation of the aspects of clinical trials that patients find particularly confusing or challenging. Collaborating with patients through one-to-one discussions, focus groups, and feedback sessions helps identify gaps in comprehension and areas of concern. This participatory approach ensures that educational interventions are relevant and responsive to real-world patient experiences.
This philosophy aligns with regulatory trends that emphasize patient-centricity. Agencies such as the FDA and EMA increasingly recognize the importance of integrating patient perspectives to ensure that clinical trials reflect real-world needs and values. The FDA has launched the Patient-Focused Drug Development (PFDD) initiative to gather patient input systematically throughout the drug development lifecycle. Similarly, the EMA emphasizes the use of Patient Experience Data (PED) to inform clinical trial design, endpoint selection, and benefit-risk assessments.
2. Developing educational materials to improve patient understanding
Once patient needs are identified, these can be addressed through tailored educational materials. Such resources may include videos, guides, or interactive content designed to clarify the topics that patients most often report as unclear or insufficiently explained during their clinical trial experience. At Kayentis, we created a Patient Education Video Library, co-developed with patient advocates and integrated directly into our eCOA application. This library features short, targeted videos that respond to key concerns frequently expressed by clinical trial participants, such as understanding the value of clinical trials, recognizing the role of caregivers, and clarifying how personal data are handled. By embedding these videos in the digital tools patients already use, accessibility and impact are maximized. In this way, we aim to deliver relevant information at the right time and in the right context, thereby reducing technical barriers and fostering greater understanding, trust, and engagement throughout the clinical trial journey.
3. Driving trial efficiency and long-term value for sponsors
Clinical trials are complex, resource-intensive endeavors where every dropout, protocol deviation, or data inconsistency can lead to delays, increased costs, and compromised outcomes. By proactively addressing patient uncertainty and disengagement through educational video content, we help mitigate these risks at their source. To further support inclusivity, these videos should be made available in the patient’s language, ensuring that all participants can fully benefit from the educational content. Sponsors may also provide additional video content that can be incorporated into the platform, offering a comprehensive educational experience.
Informed patients are not only more likely to remain in the study, but are also more likely to complete assessments accurately, adhere to timelines, and require less intervention from site staff. This reduces the operational burden on clinical teams and enhances overall trial efficiency. Moreover, when patients understand the purpose and impact of their participation, they are more likely to become advocates for the study, contributing to a more positive trial culture and potentially supporting future recruitment efforts.
Embedding targeted educational content and support directly in the digital tools used by patients reflects a broader industry shift toward sustainable, patient-centered research models. Sponsors are increasingly evaluated not just on trial outcomes, but on how they engage and support participants throughout the process . This strategy enables Sponsors to meet both regulatory expectations and ethical responsibilities, while also improving the likelihood of trial success.
