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Patient Engagement, People with Lived Experience

Definition: People with Lived Experience (PWLE) include individuals who have firsthand knowledge and understanding of specific challenges or circumstances, such as mental health conditions, substance use, homelessness, chronic illnesses, trauma, incarceration, disability, poverty, systemic oppression, or migration and refugee experiences. This group also extends to caregivers, families, and support networks who share in these experiences by providing care, advocacy, or navigating these challenges alongside their loved ones. Their collective insights, shaped by both direct and shared experiences, provide valuable perspectives that are often absent from traditional frameworks. Recognizing PWLE—including those personally impacted and their support systems—as experts fosters a more inclusive approach to policymaking, research, and service delivery. By integrating their voices into these processes, we can create solutions that are not only more effective and equitable but also grounded in the realities of those directly impacted.

Summary: Patient engagement in clinical trials is no longer a nice-to-have—it’s a necessity. By learning from trailblazers like PCORI, the Veterans Administration, and global initiatives, we can transform clinical research into a truly patient-centered endeavor. This article explores key lessons and actionable strategies to empower patients, enhance diversity, and improve the relevance and impact of clinical trials worldwide.

What if clinical trials were not just about People with Lived Experience (PWLE), but powered by them?

Across the globe, innovative organizations like PCORI in the U.S., the Veterans Administration (VA), and international research networks are rewriting the rulebook on patient engagement. By inviting People with Lived Experience (PWLE) to co-design trials, prioritize outcomes that matter most to them, and share decision-making, they are proving that meaningful collaboration does not just improve recruitment—it leads to better science. Here is how we can take these lessons and create a future where every clinical trial is patient-centered, impactful, and inclusive.

1. Empowering PWLE as Research Partners

• Lesson: PWLE should be active collaborators, not just trial participants. Involving PWLE early ensures that the research aligns with their priorities and needs.
  • PCORI involves PWLE at every stage of research. Learn more: https://www.pcori.org/about/about-pcori/our-programs/engagement.
  • The VA’s Veteran Engagement Groups ensure veterans guide research priorities: https://www.hsrd.research.va.gov/for_researchers/veteran_engagement.cfm
• Application: Create patient advisory boards for clinical trials to co-develop protocols, recruitment strategies, and study designs. Engage PWLE in brainstorming sessions to incorporate their lived experiences into trial planning.

2. Addressing Real-World Needs

• Lesson: Trials must focus on outcomes that matter to patients, such as quality of life or day-to-day challenges, not just clinical endpoints.
  • PCORI prioritizes funding for patient-relevant research questions: https://www.pcori.org/engagement-research/value-engagement-research.
  • The VA aligns its research with the health challenges faced by veterans: https://www.hsrd.research.va.gov/.
• Application: Survey PWLE before trial design to understand what outcomes they prioritize. Tailor endpoints to include patient-reported outcomes like fatigue, mobility, or emotional well-being.

3. Building Trust Through Transparency

• Lesson: Open and honest communication about study goals, risks, and outcomes builds participant trust and improves recruitment and retention.
  • PCORI’s transparency and engagement efforts foster trust: https://www.pcori.org/about/about-pcori/our-vision-mission.
  • The VA ensures veterans are informed about research objectives: https://www.research.va.gov/about/.
• Application: Develop clear, jargon-free materials explaining the study’s purpose, procedures, and benefits. Provide regular updates to participants about progress and preliminary findings to maintain transparency.

4. Enhancing Diversity and Inclusion

• Lesson: Active engagement is required to reach underrepresented populations, such as racial minorities, rural communities, or individuals with disabilities.
  • PCORI supports initiatives to address health equity and engage underserved populations: https://www.pcori.org/about/about-pcori/pcori-strategic-plan.
  • The VA focuses on ensuring diverse representation in veteran research: https://www.research.va.gov/about/strategic_priorities.cfm
  • NIHR emphasizes inclusion in patient involvement: https://www.nihr.ac.uk/about-us/who-we-are/research-inclusion/diversity-data.
• Application: Partner with community organizations to recruit diverse participants. Use culturally tailored recruitment materials and provide multilingual resources to reduce barriers to entry.

5. Simplifying Study Design and Communication

• Lesson: Complex study designs and dense language can deter participants. Simplifying the process encourages greater engagement.
  • PCORI’s plain language summaries ensure accessibility: https://www.pcori.org/blog/assessing-research-quality-getting-word-out-widely.
• Application: Simplify consent forms and trial instructions using plain language. Use visual aids and videos to explain trial details. Pilot materials with PWLE to ensure comprehension.

6. Leveraging Digital Tools for Engagement

• Lesson: Technology allows researchers to engage patients more effectively, especially in remote areas.
  • VA’s My HealtheVet portal enhances engagement through digital tools: https://www.myhealth.va.gov/.
  • Australia’s Clinical Trials website simplifies digital trial participation: https://www.australianclinicaltrials.gov.au/.
• Application: Use apps or online platforms for recruitment, real-time data collection, and PWLE feedback. Develop interactive portals where PWLE can track their participation and access study-related information.

7. Creating Feedback Loops

• Lesson: Keeping participants informed about the trial’s progress and results builds long-term trust and engagement.
  • PCORI emphasizes feedback and dissemination in its engagement rubric: https://www.pcori.org/engagement.
  • VA researchers routinely update veterans on project results: https://www.research.va.gov/.
• Application: Send participants periodic updates about the study, including key milestones and preliminary findings. At the conclusion, provide participants with accessible summaries of the trial results.

8. Institutionalizing Engagement Practices

Lesson: Sustainable patient engagement requires organizational policies and funding to support it.

• PCORI has institutionalized patient engagement standards: https://www.pcori.org/research/about-our-research/research-methodology/pcori-methodology-standards.
• NIHR has embedded patient involvement frameworks into its research funding: https://www.nihr.ac.uk/news/nihr-announces-new-standards-public-involvement-research.
• Application: Establish policies that require patient engagement in all clinical trials. Allocate specific funding for patient engagement activities, such as advisory boards and outreach initiatives.

9. Measuring Engagement Impact

• Lesson: Metrics help evaluate whether engagement strategies improve outcomes like recruitment, retention, and patient satisfaction.
  • PCORI provides tools to measure the impact of engagement: https://www.pcori.org/engagement/engagement-resources/Engagement-Tool-Resource-Repository?keyword=&f[0]=resource_focus:3362.
• Application: Develop key performance indicators (KPIs) for engagement, such as recruitment rates, participant diversity, and satisfaction scores. Use patient feedback to refine engagement strategies.

10. Fostering Global Collaboration

• Lesson: Sharing strategies across countries enhances engagement practices.
  • Canada’s Strategy for Patient-Oriented Research (SPOR) fosters collaboration: https://cihr-irsc.gc.ca/e/45851.html.
  • NIHR’s global partnerships focus on patient-centered research: https://www.nihr.ac.uk/research-funding/global-health.
• Application: Collaborate with international organizations to adopt successful models of patient engagement. Share best practices at global forums and incorporate learnings into local trials.

Conclusion: The future of clinical trials lies in meaningful patient engagement—where participants are not just subjects, but partners in research. By embracing the lessons from organizations like PCORI, the Veterans Administration, and global leaders, we can create trials that are more inclusive, impactful, and aligned with real-world needs. This is not just about improving recruitment or retention; it’s about elevating the science itself. When patients are empowered to guide the research that directly affects their lives, the results benefit everyone—patients, researchers, and the healthcare system as a whole. It’s time to transform how we design and conduct trials, one partnership at a time.