Abstract
Clinical trials hold incredible potential to improve lives, but too often, they fall short of addressing the real-world challenges faced by participants. Engaging People with Lived Experience (PWLE)—those directly affected by the conditions being studied—can change this by ensuring research is meaningful, inclusive, and impactful. Drawing from principles like Deming’s quality management, Toyota’s Genchi Genbutsu (“Go Look, Go See”), and modern approaches like Agile, Design Thinking, and Co-Creation, this paper makes the case for embedding PWLE as team members in clinical trials. By learning from initiatives such as the NIH HEAL Initiative, the Clinical Trials Transformation Initiative (CTTI), the Patient-Centered Outcomes Research Institute (PCORI), and international organizations like EUPATI, we show how PWLE engagement leads to better outcomes, stronger trust, and research that truly reflects participants’ needs.
Introduction
Clinical trials are the foundation of medical progress, but for many participants, they feel inaccessible, irrelevant, or unresponsive to their realities. People with Lived Experience (PWLE)—individuals who live with or care for those with the conditions being studied—are uniquely positioned to close this gap. By involving PWLE in the design, execution, and dissemination of trials, researchers can build studies that work better for everyone involved.
But PWLE engagement requires more than good intentions. It demands systemic change. Fortunately, proven principles from business management and human-centered design offer a clear path forward. W. Edwards Deming’s focus on systems thinking, continuous improvement, and respect for individuals provides a powerful foundation. Toyota’s Genchi Genbutsu (“Go Look, Go See”) emphasizes the importance of firsthand observation, while its focus on eliminating inefficiencies (Muda) ensures respect for time and resources. Agile methodologies and Design Thinking bring flexibility and empathy to the table, fostering iterative collaboration with PWLE.
Real-world examples of initiatives like NIH HEAL, PCORI, and EUPATI show how engaging PWLE leads to higher retention, more effective recruitment, and greater trust between participants and researchers. This paper explores these principles and success stories, presenting actionable recommendations for making PWLE an essential part of every clinical trial team.
Business Principles That Support PWLE Engagement
1. Deming’s Principles: A Foundation for Systemic Change
W. Edwards Deming revolutionized business with his focus on improving quality through systems thinking, respect for individuals, and continuous learning. These principles translate seamlessly into clinical trials:
Constancy of Purpose: A long-term commitment to engaging PWLE ensures their voices are part of every stage of research, from design to dissemination.
Systems Thinking: Clinical trials are complex, and PWLE can help researchers see how various elements—protocols, logistics, communication—affect participant experiences.
Respect for Individuals: Valuing PWLE contributions through equitable compensation and clear roles builds trust and ensures meaningful collaboration.
Continuous Improvement: PWLE feedback should drive iterative refinements to study designs, materials, and recruitment strategies.
Reference: Deming, W. E. (1986). Out of the Crisis. MIT Press.
2. Toyota’s Lean Management Principles
Toyota’s approach to efficiency and quality offers practical tools for engaging PWLE:
Genchi Genbutsu (Go Look, Go See): Researchers can learn a lot by observing PWLE in their environments—whether that’s navigating a clinic or managing a chronic condition at home.
Muda (Eliminating Waste): Inefficient processes like redundant surveys or inaccessible forms waste participants’ time and energy. Involving PWLE can help identify and eliminate these barriers.
Kaizen (Continuous Improvement): Like Deming, Toyota emphasizes the importance of iterative refinements. PWLE insights can guide ongoing improvements in trial protocols and engagement practices.
References:
Ohno, T. (1988). Toyota Production System: Beyond Large-Scale Production. Productivity Press.
Liker, J. K. (2004). The Toyota Way. McGraw-Hill Education.
3. Design Thinking and Agile Methodology
Design Thinking prioritizes empathy, creativity, and collaboration—perfect for engaging PWLE. By co-creating solutions with PWLE, researchers can design trials that truly meet participants’ needs. Agile complements this by introducing flexibility and responsiveness, allowing researchers to adapt protocols based on PWLE feedback.
Example: Regular “sprint” meetings with PWLE can address emerging challenges and refine strategies in real-time.
References:
Brown, T. (2009). Change by Design. Harper Business.
Beck, K. et al. (2001). Manifesto for Agile Software Development.
4. Stakeholder Theory and Co-Creation
Stakeholder Theory emphasizes that all voices—including those of PWLE—should be considered in decision-making. Co-Creation goes further, making PWLE active collaborators in designing and executing clinical trials. This approach builds trust, fosters accountability, and ensures that trials address the issues that matter most to participants.
References:
Freeman, R. E. (1984). Strategic Management: A Stakeholder Approach. Pitman.
Prahalad, C. K., & Ramaswamy, V. (2004). The Future of Competition: Co-Creating Unique Value with Customers. Harvard Business School Press.
Real-World Success Stories
National Initiatives
NIH HEAL Initiative
A HEAL-funded chronic pain study engaged Advisors with Lived Experience to identify barriers like rigid clinic schedules and overly complex consent forms. Their input led to the introduction of telehealth options and simplified materials, resulting in a 40% increase in retention.
Reference: NIH HEAL Initiative. (2024). Progress Reports on Pain and Addiction Research.
Clinical Trials Transformation Initiative (CTTI)
CTTI involved PWLE in reviewing consent forms for a cardiovascular trial. Their feedback improved clarity, reducing participant confusion and boosting enrollment rates by 25%.
Reference: Clinical Trials Transformation Initiative. (2023). Recommendations for Improving Participant Engagement.
Patient-Centered Outcomes Research Institute (PCORI)
In a PCORI-funded opioid use study, PWLE co-created recruitment materials tailored to underserved communities, dramatically improving enrollment and fostering trust.
Reference: Patient-Centered Outcomes Research Institute. (2024). Engagement Strategies for Patient-Centered Outcomes Research.
International Efforts
European Patients’ Academy (EUPATI)
EUPATI trains patient advocates to contribute as co-researchers. In one diabetes trial, PWLE improved cultural relevance and recruitment strategies, increasing retention significantly.
Reference: European Patients’ Academy. (2023). Patient Engagement in Clinical Research: Success Stories.
INVOLVE (United Kingdom)
INVOLVE integrated PWLE into a chronic illness study, where they helped design user-friendly data collection tools, reducing dropout rates.
Reference: INVOLVE, NIHR. (2022). Patient Involvement in Research.
Recommendations for Making PWLE Team Members
Institutionalize PWLE Roles:
Create formal roles, such as Advisors with Lived Experience, to embed PWLE in every stage of the clinical trial process.
Use Human-Centered Frameworks:
Apply Design Thinking and Agile methods to foster collaboration and adapt to PWLE feedback.
Address Barriers to Participation:
Simplify protocols, provide flexible options like telehealth, and compensate PWLE equitably to make engagement accessible.
Invest in Training:
Train both PWLE and researchers to collaborate effectively. Programs like EUPATI and INVOLVE offer excellent models.
Measure and Share Success:
Track metrics like retention rates, enrollment diversity, and participant satisfaction to demonstrate the impact of PWLE engagement.
Conclusion
The evidence is clear: engaging People with Lived Experience transforms clinical trials. By applying principles like Deming’s systems thinking, Toyota’s Kaizen, and Co-Creation, researchers can design studies that are not only scientifically rigorous but also participant centered. Initiatives like NIH HEAL, PCORI, and EUPATI show that when PWLE are treated as collaborators, research becomes more inclusive, impactful, and trusted.
PWLE are not just contributors—they are co-creators whose insights drive better science. Embedding them into clinical trials isn’t just the right thing to do; it’s the smartest way to ensure research truly serves those it aims to help.
References
Deming, W. E. (1986). Out of the Crisis. Cambridge, MA: MIT Press.
Ohno, T. (1988). Toyota Production System: Beyond Large-Scale Production. New York, NY: Productivity Press.
Liker, J. K. (2004). The Toyota Way. New York, NY: McGraw-Hill Education.
Brown, T. (2009). Change by Design. New York, NY: Harper Business.
Freeman, R. E. (1984). Strategic Management: A Stakeholder Approach. Pitman.
NIH HEAL Initiative. (2024). Progress Reports on Pain and Addiction Research. Bethesda, MD: National Institutes of Health.
Clinical Trials Transformation Initiative. (2023). Recommendations for Improving Participant Engagement. Durham, NC: CTTI.
Patient-Centered Outcomes Research Institute. (2024). Engagement Strategies for Patient-Centered Outcomes Research. Washington, DC: PCORI.
European Patients’ Academy. (2023). Patient Engagement in Clinical Research: Success Stories. Brussels: EUPATI.
INVOLVE, NIHR. (2022). Patient Involvement in Research. London: National Institute for Health Research.
(Researched, written, and edited with help from ChatGPT 4.0)