FDA Encourages Greater Trial Diversity

The FDA has issued final guidance on increasing diversity in clinical trials. The document urges trial sponsors to broaden eligibility criteria; eliminate restrictions when appropriate as studies progress; and take steps to attract participants of different ages, genders, races, and ethnicities.

“Diversity is generally expected but not a hard requirement for most clinical trials, so it's important for sponsors to require detailed plans to engage, enroll, and retain participants from diverse groups,” says Luis Carvajal-Carmona, PhD, of the University of California (UC) Davis Comprehensive Cancer Center in Sacramento and a member of the American Association for Cancer Research's Minorities in Cancer Research (MICR) Council. To that end, he says it's helpful to have the official guidance from the federal government.

Although exclusions may be necessary to protect people at higher risk for adverse events, such as pregnant women or people with underlying illnesses, these criteria should be examined closely and eliminated if appropriate, according to the FDA. For example, it might make sense to exclude patients with advanced heart failure but not those with milder cardiac disease.

“Exclusions often go against minority and low-income communities, where the prevalence of comorbidities, such as hypertension, obesity, and heart, liver, or kidney diseases, tend to be higher than in the general population,” says Carvajal-Carmona. “Patients from minority groups may also have different life experiences that can impact biological processes, such as immune profiles, and potentially result in different responses to treatments.”

Similarly, exclusion criteria should be reexamined for relevance as trials progress, the FDA recommends. For example, sponsors should have strong clinical or scientific justification to exclude patients based on age, weight, or concomitant disease. In addition, some patients who are initially excluded from a drug trial due to toxicity concerns may become eligible at a later phase, based on emerging data.

“In designing trials, it's very important that we have conversations with people in community organizations and patient advocates about what they see as barriers to participation by underrepresented populations,” says Laura Fejerman, PhD, also of UC Davis and past chair of the MICR. For example, patients may live far away from the center where a relevant trial is offered, face language barriers, be too busy working, or think they lack the financial resources to participate.

Solutions, Fejerman says, might be to conduct visits in patients' homes or at a nearby community clinic, and to clearly inform patients about reimbursement of expenses, including transportation.

“For most patients, insurance typically pays some costs of participating in a trial, such as routine care leading up to when a trial begins,” Fejerman says. “If we promote trials more actively in community clinics, we should be prepared to accommodate undocumented patients who show interest by having funding available to cover their full costs of participation.”

Community outreach and engagement offices at cancer centers are a step in the right direction, says Carvajal-Carmona, but greater effort is needed to dramatically boost enrollment of minority patients.

“Institutions conducting the trials should be fully engaged in culturally and linguistically sensitive ways,” he says, “including hiring health practitioners from more diverse backgrounds who speak the patients' languages, and establishing satellite offices near where people of color and limited income live.” –Janet Colwell