Building Meaningful Patient Engagement in Clinical Research: The PROACT EU-Response Training Programme
Delivering patient-centred clinical research requires researchers to understand how patients can contribute as partners throughout the research process, from study design and implementation to dissemination of results. Recognising that awareness and experience of patient involvement and engagement remain limited across parts of the research community, PROACT EU-Response focused on strengthening the capacity of its consortium partners to work meaningfully with patients.
To support this objective, the European Patients’ Forum (EPF) developed a dedicated training programme on patient engagement and patient involvement for researchers, clinicians, technical experts and project teams across the consortium. While patient engagement and patient involvement are closely related, they are not synonymous. Patient engagement encompasses the broader interactions between researchers and patients, while patient involvement refers to patients working as active partners in shaping research. The training explored both concepts, with a particular emphasis on meaningful patient involvement throughout the clinical trial lifecycle.
Why was a Patient Engagement Training needed?
Before designing the training programme, EPF conducted a survey among all PROACT EU-Response project partners between April and May 2025 to assess their familiarity with patient involvement and engagement and identify their learning needs, gaps, and expectations. The findings demonstrated the need for a structured and high-quality training programme with 80% of respondents stating that they “have not previously participated in any patient engagement training”.
The survey revealed that while approximately two-thirds of respondents had some familiarity with patient engagement approaches including Patient Advisory Boards (PABs) and Community Advisory Boards (CABs), significant gaps remained. Around one-third of partners reported little or no experience with patient engagement or associated it only with basic informed consent procedures. This showed the need for introductory and foundational training on the principles of meaningful patient engagement and involvement.
Project partners also identified a range of operational and institutional challenges that hinder effective patient engagement and involvement, including:
- Lack of resources such as time, funding, and dedicated staff
- Difficulties recruiting representative patients, particularly in acute illness contexts
- Complex medical language and low health literacy
- Limited institutional guidance and organisational support
- Ethical uncertainties and misaligned expectations between researchers and patients.
The survey further informed the preferred format of the training. Most respondents favoured live online sessions delivered in shorter modules, allowing flexibility and accessibility across the consortium. More than 84% of respondents also expressed strong interest in follow-up resources, toolkits, and additional support after the training.
Designing the Training Programme
In response to the survey findings, EPF collaborated with the European Patients’ Academy of Therapeutic Innovation (EUPATI) to co-develop a tailored training programme addressing both foundational and advanced concepts in patient engagement and involvement. The programme was designed to be relevant across different professional roles and varying levels of prior experience.
Three interactive online sessions were organised in March and April 2026, each lasting 90 minutes and combining presentations, discussions, and various exercises. The sessions were facilitated by experts including Dr. Tamás Bereczky, Inês Alves, and Dr. Ingrid Klingmann.
Session 1: Foundations of Patient Involvement
The first online training session, held on 19 March 2026, focused on introducing the core principles of patient involvement in clinical research. The session was attended by 28 people. Participants explored why patient involvement matters, how patients can be involved as partners, and the importance of building long-term collaborative relationships.
Key topics included:
- The rationale for patient involvement in research
- Different models of engagement and communication
- The roadmap for patient involvement throughout research and development
- Principles of patient involvement in clinical trials.
The session also incorporated interactive case studies where participants assessed whether patient involvement approaches in clinical trials were meaningful or tokenistic. A concluding exercise invited participants to reflect on whether their perception of patient involvement had changed after the session.
Session 2: Ethical and Regulatory Dimensions
The second training session, held on 26 March 2026, addressed the ethical, regulatory, and operational aspects of patient involvement in clinical research. The session was attended by 22 people.
Participants explored:
- Regulatory frameworks governing patient involvement
- Ethical considerations in clinical trials
- Principles for selecting and engaging patients appropriately
- The role of patient-reported outcomes (PROs) and patient experience data.
Interactive discussions examined evolving regulatory environments, including the impact of Health Technology Assessment Regulation (HTAR), artificial intelligence, and data protection considerations such as GDPR. Participants were encouraged to reflect on practical challenges and opportunities associated with integrating patient perspectives into increasingly complex regulatory systems.
By focusing on ethics and regulation, the session helped participants better understand how patient involvement can be implemented responsibly, transparently, and in compliance with evolving European standards.
Session 3: Inclusion and Underrepresented Populations
The third and final session, held on 1 April 2026, focused on diversity, equity, inclusion (DEI), and the involvement of underrepresented populations in clinical trials. The session was attended by 14 people.
Topics included:
- Real-world examples of patient involvement
- Intersectional methodologies in clinical research
- Understanding underrepresentation in trials
- Barriers to inclusion and strategies to overcome them.
Participants engaged in discussions exploring how to better involve underserved populations in clinical trials and identify actionable solutions to common barriers. Interactive exercises encouraged reflection on dimensions of non-representativeness and inclusion blind spots within research practices.
Evaluation, Feedback and Impact
The PROACT EU-Response patient engagement training series received very positive feedback across all three sessions, highlighting strong participant satisfaction, practical learning outcomes, and increased awareness of meaningful patient involvement in clinical research.
Some of the main learnings mentioned by participants in the follow up survey include:
- “Understanding the difference between patient engagement and meaningful patient involvement.”
- “Stronger understanding of patient involvement within regulatory systems.”
- “Greater awareness of the challenges faced by underrepresented populations in clinical research.”
The training programme established a shared understanding of meaningful patient involvement across the PROACT EU-Response consortium and laid the foundations for embedding patient perspectives throughout the project. Developed in response to an identified need for capacity building, the training equipped participants with practical knowledge on patient engagement principles, ethical and regulatory considerations, and inclusive approaches to involving underrepresented populations.
Through interactive discussions, practical examples and case studies, the programme gave partners greater confidence in working with patients throughout the clinical trial lifecycle. It also supports the work of the project’s Patient Advisory Group (PAG) and Patient Engagement Ambassadors (PEAs), helping researchers and patient partners collaborate more effectively from study design to dissemination. By building a shared understanding of meaningful patient involvement, PROACT EU-Response is helping ensure that patients’ perspectives are considered throughout the design, conduct and dissemination of its clinical research.
