Johnson & Johnson on How To Truly Diversify Clinical Trials

Originally published at Johnson & Johnson is a Hall of Fame company.


It’s no surprise that medications work differently in different people. Everything from age to weight to genetic makeup can play a role in an individual’s response to treatment.

Yet there’s a stunning dearth of information about how different treatments may affect different racial and ethnic groups. That’s due in large part to the fact that people of color have been historically underrepresented in clinical trials, which are studies that evaluate the safety and efficacy of investigational medications. And that paucity of data only exacerbates many of the other health disparities that people from historically marginalized groups face, like a lack of access to care, lower rates of health insurance coverage and higher rates of certain severe diseases.

2021 analysis revealed that more than 40% of 230 U.S.-based trials didn’t report the race of participants, and almost 65% didn’t report ethnicity. Of those that did report race, 78% of participants were white, while just 11% were Black, 6% were Asian and less than 1% were Native American — and in studies reporting ethnicity, only 11% of participants were reported as Hispanic or Latino.

These disparities pose an urgent problem that Johnson & Johnson is meeting head-on. In 2020, the company launched Our Race to Health Equity — a commitment to close the racial health gap so that the color of your skin is not a determinant of your access to care, quality of care or health outcomes. This initiative involves working to increase diversity in clinical trials.

“We should be designing clinical trials for the patients we’ll treat or who will use our treatments,” says Staci Hargraves, Vice President, Patient and Portfolio Solutions at the Janssen Pharmaceutical Companies of Johnson & Johnson, and Executive Sponsor of Janssen’s Diversity, Equity and Inclusion in Clinical Trials program. This includes trials for investigational medications that treat diseases that disproportionately affect people of color, such as lupus and multiple myeloma.

And increasing the number of people of color in clinical trials is just the beginning, she says. Janssen is examining how clinical trials are designed, the exclusion and inclusion criteria for participants and how clinical trial site staff are engaging with different communities and interacting with people of color. Increasing diversity also involves addressing barriers to enrolling in clinical trials that groups historically excluded sometimes face, Hargraves explains.