Putting People With Lived Experience at the center of research, guidelines, and health care.
When I first entered the world of clinical trial research, I heard the term “stakeholders” over and over. It was the word everyone used—sometimes loosely, sometimes with precision. But over time, I realized that the phrase could blur the most important distinction of all: the difference between stakeholders and People With Lived Experience (PWLE).
Getting this difference right isn’t just wordplay. It determines who has a voice at the table, how research is shaped, and whether patients truly benefit.
What Are Stakeholders?
In clinical trial research, stakeholders are broadly defined as anyone with a vested interest in the study’s outcomes. That includes:
- Patients and caregivers
- Clinicians, nurses, and allied health professionals
- Researchers and academics
- Policy makers and regulators
- Payers, insurers, and industry partners
- Advocacy organizations
Stakeholders matter because they all influence how research questions are asked, funded, regulated, and implemented.
But here’s the problem: when everyone is labeled a “stakeholder,” the patient voice can disappear into the crowd.
What Makes PWLE Different?
PWLE are not just one type of stakeholder. They represent a distinct, essential category: the people whose lives are directly affected by the condition or treatment being studied.
PWLE includes:
- People living with the condition (chronic pain, cancer, diabetes, etc.)
- Survivors who carry the long-term impacts of illness or treatment
- Caregivers and family members who share the burden and reality of care
- People from communities historically excluded or marginalized in research
Unlike other stakeholders, PWLE bring a kind of expertise no professional training can supply: the lived reality of navigating illness, pain, care systems, stigma, and recovery.
That perspective cannot be substituted by clinicians, policy makers, or even advocates who don’t share that personal experience.
Where Do They Fit in Clinical Trials?
If we’re serious about patient-centered research, PWLE need to be engaged at every stage of the trial process, not just as “participants” in the study.
- Defining the question: PWLE help identify whether the research is asking the right question from the patient’s perspective.
- Designing the study: PWLE highlight barriers to recruitment and retention, suggesting designs that reflect real-life needs.
- Grant applications: Their voices strengthen the case for relevance and impact.
- Conducting the study: PWLE advisors help make participation more feasible and less burdensome.
- Analyzing results: PWLE offer context for what findings mean in the real world.
- Dissemination: PWLE ensure that results are communicated in plain language and shared in places patients actually access.
PWLE are not “add-ons.” They are co-creators of knowledge.
Final Thought
Stakeholders are broad. PWLE are specific. Both matter, but they are not interchangeable. If researchers don’t name this distinction, patients risk becoming invisible in a sea of voices.
When PWLE are recognized as a unique, essential part of the research team, clinical trials move from theory to lived relevance. That’s how we get results that truly matter—and how we move research forward with patients, not just about them.
Acknowledgment: This article was developed with assistance from ChatGPT.