Thanks to patient advocacy efforts, researchers are doing more to ensure people from all communities can more easily participate in and benefit from clinical studies.
Only 5% of the U.S. population has ever enrolled in a clinical study, driven by a widespread sense that research is inaccessible, hard to understand, or too burdensome of a commitment. The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) is partnering with academic institutions, industry, nonprofits, governments, and patient advocacy groups to make research more patient-centered.
In plain language, please
One of the center’s health literacy projects is a plain-language Clinical Research Glossary, a free online resource that Sylvia Baedorf Kassis, MPH, her colleagues, and a diverse workgroup of representatives from across the industry have been developing after finding nothing like it in the clinical research landscape. For study participants who don’t know what a double-blind, randomized control trial is—or study designers who aren’t sure how to explain this concept simply—the glossary defines it with examples and illustrations.
The glossary’s entries have been translated into 55 languages, thanks to AI-enabled translation. While not yet validated by native speakers, communicating users’ preferred language is an area of active work by the MRCT Center and Mass General Brigham.
“Research is essential to making progress with treating, ameliorating, and preventing disease,” says Barbara Bierer, MD, faculty director of the MRCT Center. “As researchers, we can’t continue ignoring communications and access issues causing so many people to be underrepresented in research and, consequently, underserved in healthcare.”
Historically, clinical trials have also been geographically exclusionary, Bierer notes. Most people nationwide receive care in community-based hospitals and clinics, yet studies that might benefit them are usually based in large, urban academic medical centers.
“We haven’t had a good system for communicating with patients about opportunities to participate in clinical studies,” she adds. “Patients usually learn about a trial through an intermediary, like their healthcare provider, who likely also doesn’t have easy access to a list of additional trials patients might be interested in or qualify for.”
“Can you imagine if we had simple, plain-language summaries across all scientific publications? How amazing would that have been during COVID for people who don’t have an infectious disease or epidemiology background?”
Willyanne DeCormier Plosky, DrPH
Bringing research within reach
Without clear recruitment strategies, unintentional biases can make research participation less likely for individuals of color and those with limited English proficiency, lower health literacy, socioeconomic hardships, and disabilities.
As the MRCT Center’s Diversity, equity, and Inclusion program director, Willyanne DeCormier Plosky, DrPh, works with her team to develop evidence-based toolkits and checklists to help study designers, funders, and regulators be more proactive in including patients who are underserved in research.
“The key points we emphasize to researchers are to make sure they have direct communication lines with patient communities,” she says. “Then, put things in plain language—with translation—and make participation financially possible. Finally, ensure that traditionally underrepresented people are at the table throughout the trial planning and reporting process.”
Clinical study participants can be surprised when they never hear about study results. To address this, the MRCT Center encourages researchers to provide plain-language summaries to participants and simplify the technical language in abstracts they submit to medical journals.
“Can you imagine if we had simple, plain-language summaries across all scientific publications?” DeCormier Plosky says. “How amazing would that have been during COVID for people who don’t have an infectious disease or epidemiology background?”
Making research more equitable and inclusive helps everyone involved, she says.
“Curb cutouts in sidewalks were installed to help people using wheelchairs safely maneuver into the street, but those ramps help all kinds of people—from parents with strollers to skateboarders and bikers,” says DeCormier Plosky. “When you plan for universal design in your communication and physical environments, everyone benefits.”
