Broadening Clinical Trial Participation

Patient enrollment in clinical trials has long been on the minds of oncologists and researchers. In 1990, fewer than 3 percent of patients were enrolled in clinical trials—which spurred then president-elect of the American Cancer Society, Walter Lawrence Jr., MD, to write an editorial calling for more concerted efforts. More than 25 years later, clinical trial participation hovers around 5 percent.

The summer issue of Cancer Today, a magazine for patients, caregivers, and survivors that is published by the American Association for Cancer Research, explores ways researchers and physicians are trying to increase clinical trial participation.

“If you think trials are important, then you have to believe having adequate representation of all populations is important, because that is how we will make sure trial findings are representative and generalizable,” said Susan Eggly, PhD, a communication researcher at Wayne State University School of Medicine and Karmanos Cancer Institute in Detroit. “Given that clinical trials are considered the highest-quality care available, it is important to make sure everyone—minorities, women, older people, and rural populations—has equal access to care. And we know right now they don’t.”

A Call for Modernization

Modernizing clinical trial eligibility criteria is an important first step, according to Edward S. Kim, MD, a medical oncologist at Carolinas HealthCare System’s Levine Cancer Institute in Charlotte, North Carolina. “We used to think that there were not enough trials,” Kim said. “That’s not the problem. The problem is we are excluding people unnecessarily.” Kim headed a committee that tackled this common problem—first looking at why people with brain metastases, organ failure, or diseases like HIV or hepatitis C are routinely excluded from trials.

Exclusion criteria can also leave out other types of patients, including older people who have comorbidities. Diabetes, asthma, and obesity are diseases often related to poverty that can also limit the types of people who can be included, said Stuart Lichtman, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York, who believes that criteria can be modified to reflect real-world data.

Racial and ethnic minorities are typically underrepresented in clinical trials, as well. In 2008, the Intercultural Cancer Council (ICC) published findings from a four-year project, Eliminating Disparities in Clinical Trials, that explored these imbalances. The report served as a springboard for discussion, said Armin Weinberg, PhD, a health policy researcher at Baylor College of Medicine in Houston and a co-founder of the ICC.

Weinberg notes it isn’t enough to recruit minorities. Efforts also need to retain participants by addressing barriers such as language, transportation, or insurance coverage. As an additional step, researchers should also share the results of the trials with participants. He coins these collective efforts as the three Rs: recruitment, retention, and return.

Federal agencies have also made continuing efforts to be more inclusive. The National Institutes of Health requires researchers to explain in their grant applications how they will recruit racial and ethnic groups. The U.S. Food and Drug Administration (FDA) also provides guidance for collecting racial and ethnic data on study participants. In 2015, the FDA launched Drug Trials Snapshots, which presents pie charts of the sex, race, and age of participants who took part in the study for FDA approval.

To learn more about other efforts, including expanding access to clinical trials for people in rural areas, and for older people, go to “A New Look for Clinical Trials” on the Cancer Today website.