Cancer clinical trials hold the promise of tomorrow’s treatments, yet for decades, they’ve often excluded large swaths of patients who need them most. Strict eligibility rules designed for safety and clear data—such as limits on age, prior health conditions, or comorbidities—have sidelined rural residents, people of color, older adults, LGBTQ+ individuals, and those with language barriers or limited insurance. These criteria, while rooted in protecting participants and ensuring study integrity, created a narrow participant pool that didn’t mirror real-world cancer patients, limiting how well trial results apply to everyone.
Historical data reveals the depth of this issue. Studies show trials frequently exclude based on performance status, organ function, or mental health concerns, even when controlled, leading to underrepresentation. For instance, Black and Hispanic patients made up just 5% of participants in many studies from 2015-2019, despite higher cancer burdens in these communities. Older patients over 65 are notably absent, as are those with common realities like diabetes or prior cancers. This lack of diversity means treatments succeeding in trials may not work as well—or at all—for excluded groups, perpetuating inequities in care.
Practical hurdles compound the problem. Many trials run only at distant academic centers, demanding costly travel, time off work, and childcare that low-income or rural families can’t manage. Mistrust from past medical abuses, like the Tuskegee study, lingers, especially among minorities. Language gaps, complex consent forms, and unaware community doctors further block access. Providers cite time constraints and colleague non-cooperation, while institutions lack policies or logistics like interpreters and stipends.
Change is underway, driven by advocates, researchers, and federal pushes like the FDA’s diversity action plans. Community oncology partnerships now host trials at local clinics, slashing travel needs. Eligibility is loosening: age caps are rising, prior cancers are reevaluated if stable, and comorbidities are included if managed. Multilingual materials, cultural outreach, and dedicated navigators—trained to handle logistics, build trust, and prescreen patients—bridge gaps. Institutions are adding incentives, streamlined IRBs, and diversity-focused teams.
Patient stories illuminate progress. A rural breast cancer survivor shared how a local trial navigator arranged telehealth visits and gas cards, making participation feasible despite 100-mile drives. An LGBTQ+ patient noted inclusive consent processes that respected pronouns and partners, fostering safety. These shifts not only boost enrollment but enhance science—diverse data yields broader, more reliable results.
