As we mark World Cancer Research Day on Friday, the issue of unequal representation in clinical trials and cancer research initiatives remains a persistent problem in the United States.
The sad truth is that, across most cancers, Black Americans have the highest death and shortest survival rates of any racial or ethnic group. To correct course, the health care community must take steps to increase representation of minority groups in clinical trials and help them take better advantage of life-saving technology and therapies.
Disparities in clinical trials have been a concern for decades, but it’s generated more attention as the field of precision medicine has taken off. As targeted therapies become a reality — and as dozens of personalized medicines on the market help patients live longer lives — we must do more to consider differences between people of varying races, ethnicities and gender.
Certainly, some genetic mutations are more common among different demographic populations. For example, Black women in the U.S. are three times as likely as women of other ethnic or racial backgrounds to be diagnosed with triple-negative breast cancers, for which there still isn’t effective treatment. Underscreening is also responsible for higher cancer diagnoses and deaths among African Americans.
Still, a major contributor to this outcome disparity is the underrepresentation of African Americans in oncology clinical trials. Research shows that Black Americans, who make up roughly 14 percent of the U.S. population, account for only 3.1 percent of participants in clinical trials for cancer drugs — meaning Black enrollees are represented at only 22 percent of the expected level.
This lack of proportional representation is damaging to science and limits our ability to consider potential differences — and develop effective treatments — across population subgroups. Without more minorities and women in trials, we can’t effectively determine how someone’s race, ethnicity or even gender might impact their response to a particular treatment. It calls into question the accuracy of screening recommendations — such as for lung cancer — which could foment distrust of the medical system. It also means that Black patients with advanced cancer who have exhausted other treatment options are not getting access to experimental drugs that might extend their lifespan.
This problem of underrepresentation has a long history that is, in part, the result of a deep-seeded distrust of the medical system — rooted in infamous events such as the Tuskegee Syphilis Study. But it’s also the result of poor enrollment practices by researchers. Black patients too often don’t have adequate information about trials and how they can participate.
There are clear steps that lawmakers and the health care industry can take to correct these deficiencies.
From a policy perspective, the Food and Drug Administration must continue its critical educational work through the Project Equity initiative to develop and promote policies that increase equal access to clinical trials. Educational programs, like this summer’s National Black Family Cancer Awareness campaign, are critical as we work to raise awareness among African Americans.
Congress should continue to do the hard work to advance sensible policies to support better trial recruitment. For example, the bipartisan Diversifying Investigations Via Equitable Research Studies for Everyone, or DIVERSE, Trials Act would enable the Department of Health and Human Services to provide grants to bolster education and recruitment for clinical trials for diseases that disproportionately impact underrepresented groups. Introduced by Reps.Larry Bucshon, R-Ind., and Raul Ruiz, D-Calif., the legislation would also improve data collection requirements to ensure that we have the necessary information to treat all patients properly — no matter their race or background.
On the clinical side, companies like Guardant Health, which I represent, have made concerted efforts to increase African American participation in trials. More than 10,000 patients are participating in Guardant’s ECLIPSE clinical trial to evaluate a blood test to screen for colorectal cancer in average-risk adults. Headed by Dr. Kathryn Lang, the trial focuses on innovative patient recruitment tools, such as establishing partnerships with community physicians and attending health fairs to reach patients where they are, as well as offering mobile phlebotomy and transportation assistance so that distance or resources do not interfere with participation.
This World Cancer Research Day, we should celebrate the tremendous achievements made in oncology and our increasing ability to extinguish cancer and extend many more lives. But we must also resolve to end health care disparities in clinical trials to ensure that all Americans — no matter the color of their skin — gain access to cutting edge treatments and putting an end to this disease.
Jenn Higgins is the vice president of public affairs at Guardant Health, a precision oncology company, where she advocates policies to help expand access to oncology products and improve outcomes across the cancer spectrum.