By Ashley Hattle

When research views individuals with pain as data points on a graph or medical curiosities, clinical trials may miss the mark on patients’ true realities and needs.

A patient-centered approach prioritizes the inclusion of people with lived experience (PWLE) as experts and partners in the full research process. The following U.S. organizations and initiatives are among those championing that approach.

PCORI: Making patient inclusion a requirement

The Patient-Centered Outcomes Research Institute (PCORI) funds clinical research that unequivocally centers the patient voice. The organization requires researchers to engage PWLE early and often, include them in research decisions, and compensate them.

Beth Darnall, PhD, professor of anesthesiology, perioperative, and pain medicine at Stanford University School of Medicine, has led several PCORI-funded studies. One, the EMPOWER Study, focused on behavioral support for voluntary opioid tapering in almost 600 patients.

“Patients were being tapered from their opioid prescriptions rapidly, and this was causing risks, harms, and tragically, even deaths,” Darnall explains. Over 100 patient advisers provided meaningful insight.

The VALUE Study examined the benefits, side effects, stigma, and barriers experienced by 750 individuals prescribed opioid medications for pain.

“Patients selected key measures based on what mattered most to them,” Darnall shares. “One patient created the study name.”

She also self-funded an international study—recruiting 3,500 participants from 47 countries—that shed light on harm caused by the term “pain catastrophizing,” often used to describe negative thoughts and beliefs about pain. Patient partners requested the study be conducted, helped design surveys, and were listed as co-authors on the study report, published in The Journal of Pain.

Finally, Darnall is leading the active PCORI-funded national PROGRESS Study, testing two online behavioral pain treatments in 1,650 patients. PROGRESS includes over 100 patient advisers, and many members of the primary research team live with pain.

ACTTION & IMMPACT: Incorporating patients as partners

Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) is a public-private partnership funded by the Food and Drug Administration to support the development of safe, effective pain and addiction therapeutics.

ACTTION commissions annual meetings and publications through its Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), which develops recommendations to improve the design, execution, and dissemination of clinical trials focusing on pain.

“Patients as partners” was the primary focus of the 2021 IMMPACT meeting, says Katie Holzer, PhD, LCSW, assistant professor of anesthesiology at Washington University School of Medicine in St. Louis. The meeting resulted in the very first publication to provide consensus recommendations for the clinical pain research community on authentically partnering with PWLE, with Holzer serving as one of the authors.

People with pain often prioritize different endpoints than researchers, such as quality of life and functional improvements over changes in pain intensity, shares Holzer. It’s also vital that a study’s recruitment language resonates with potential participants.

“Have people with pain read through those and help you create those documents so that they’ll be more meaningful to patients,” she urges. “You’ll have more effective recruitment methods if patients are involved in designing those documents, and that can make or break a study.”

The IMMPACT meeting and publication also spotlighted challenges hindering patient participation in trials, including low compensation, lack of accommodations, or poor communication.

Engaging PWLE in study design—and making their inclusion a requirement for research funding—can help identify and eliminate some of those challenges, ultimately boosting trial enrollment, Holzer shares.

NIH: Building a foundation for true engagement

There’s no guidebook—yet—for patient partnership in clinical pain research.

The HEAL National K12 Clinical Pain Career Development Award program at the University of Michigan, funded by the National Institutes of Health (NIH), is the first program pairing researchers with not only scientific mentors, but PWLE mentors as well. The program’s PWLE Committee is designing and teaching the first curriculum for pain scientists on how to meaningfully partner with patients.

“People with pain have never been integrated to this extent, where they’re actually developing the content that’s being taught to early-stage researchers,” shares Christin Veasley, co-chair of the PWLE Committee. Veasley is the co-founder and director of the Chronic Pain Research Alliance, a collaborative advocacy initiative focused on increasing federal investment in pain research and promoting the meaningful inclusion of PWLE as true partners in research.

She also co-chairs the NIH ENGAGE Working Group, which worked for two years to create the first agency-wide guidance on patient engagement. The group’s recommendations promote authentic partnership as a standard practice in all NIH-funded clinical research—including, but not limited to, studies on pain.

“By requiring and funding the inclusion of patients as true partners in clinical research—from study design to dissemination—the NIH has an incredible opportunity to transform clinical research,” Veasley says, “so that it is more responsive and relevant to real-world needs, more trustworthy, and more likely to produce effective treatments that improve daily life for people with pain, as well as every other medical condition.”

Patient partnerships help move the needle

These types of efforts establish concrete pathways to strengthen best practices in clinical research through patient engagement.

More so, they’re putting these steps into action with PWLE and scientists who are excited to work together for better outcomes. When patients have an equal seat at the research table, everyone wins.

ORGANIZATIONS AND EFFORTS focused on equitable patient engagement in research include:

—Center for Information and Study on Clinical Research Participation (CISCRP): ciscrp.org

—Congressionally Directed Medical Research Programs (CDMRP): cdmrp.health.mil/cwg

—National Institutes of Health (NIH): partnersinresearch.nih.gov

—Patient-Centered Outcomes Research Institute (PCORI): pcori.org/engagement-research

—United States Association for the Study of Pain (USASP): usasp.org

—Veterans Affairs: bit.ly/vaengagement