According to the World Health Organization, over one million clinical trials are conducted annually across the world. In 2024, the U.S. hosted approximately 20% of all trials, followed by China and India. Imagine all those thousands of patients traveling to clinics, submitting their samples, taking their treatments, and hoping that they – or those who follow their disease path – will benefit.
People with lived experience can advise triallists on physical, economic, and psychological burdens. Patients, caregivers, and clinicians can also provide key insights on trial questions, study targets, and methodological concerns. Listening to patients and their care teams (both family members and professionals) has been shown to be beneficial to the design and conduct of clinical research. Indeed, if clinical triallists and their funders do not integrate patient and clinician voices, they are in danger of never completing their (very expensive) work. What a waste.
The good news: Dozens of guidelines exist to help researchers engage with patients.
The bad news: A shocking few use these tools – only 1% to 18% according to reviews of identified trials.
Why? According to Stuart Nicholls and Marion Campbell, whose JAMA Viewpoint shines a spotlight on patient and clinician voices in trial design: Funders, triallists, and trial networks do not know about the tools that exist. And they do not have many incentives to adopt the guidelines, even if they do know about them.
One solution: Recruit experts to deliver TED-style talks to engage people’s imaginations. Bring stakeholders together to learn about how clinical trials could better serve patients and sponsors. That’s the spirit of the annual Innovation Network Gathering. This year’s talks are being released over the next few weeks and I urge you to watch each one, starting with Tony Fantana’s call for regulatory innovation and my introduction to the rebels of health care.
Another solution: Amplify the work that Nicholls and Campbell have done to collect resources that already exist to support the inclusion of patient and clinical voices. Here are five of the guidelines and tools they share in their JAMA Viewpoint:
- Australian Clinical Trials Alliance Consumer Involvement and Engagement Toolkit
- Clinical Trials Transformation Initiative Prioritization Tool for Sponsors and Patient Groups
- James Lind Alliance Priority Setting Partnerships
- Patient Focused Medicines Development How-to Guides
- TransCelerate Biopharma, Inc. Patient Protocol Engagement Toolkit
Here’s my favorite resource: the Patient-Led Research Collaborative’s list of Long COVID research priorities, guidelines for collaboration, and scorecards (developed with the Council of Medical Specialty Societies).
Please share the resources you recommend and use in the comments. Let’s lift up examples of research conducted with patients, not just for them.
This post is the latest in my series of “Wow! How? Health” stories, also shared on LinkedIn if you want to follow the conversation on that platform.
I don’t have anything to add but I have a suggestion for the problem that trialists don’t *know* about the tools:
Where, in the pipeline of trial creation, might we insert a requirement that these tools be *promoted* and perhaps even required?
On a related note, I recall hearing years ago that trials designed with patients included have less trouble with recruitment. I don’t know if that’s been confirmed but if so, it should be a potent motivator.