In response to increased public interest, the Food and Drug Administration (FDA) provides data on the demographic makeup of clinical trials for recently approved drugs. In 2018, for example, FDA approved 59 new drugs based on the results of clinical trials involving nearly 44,000 participants. Of those, 69% were white and 56% were women. In addition, 11% of participants were Black or African American, 10% were Asian, and 14% were Hispanic. Patients age 65 and older made up 15% of trial participants.
That data, along with similar demographic information for trials for each of the 59 drugs, is highlighted in FDA’s 2018 Drug Trials Snapshot Summary Report. The agency’s Center for Drug Evaluation and Research has been issuing the reports since 2015.
Since each report covers only the small percentage of studies approved during a given year—and since there are snapshots for just four years—there are not enough data to begin to draw meaningful conclusions.
Even so, the reports deliver an important message about FDA’s commitment to transparency on clinical trial participation.
For Clinical Research Pathways and others who strive to increase diversity in clinical trials, the snapshots also are a call to action—a reminder that we have work to do to advance our goal of having clinical trials enrollment reflect the diversity of the U.S. population.
Clinical Research Pathways is tackling this challenge with an innovative approach that recognizes the singular relationship between minority patients and their health care providers. Studies show that these patients are more likely to enroll in a clinical trial at the recommendation of a trusted provider of the same race or ethnicity. Therefore, Clinical Research Pathways has partnered with Morehouse School of Medicine in Atlanta to train and mentor minority physicians to serve as clinical investigators.
Through this partnership, we are opening doors for clinical investigators and their patients. Equally important, we are helping ensure that new medicines are effective for all patients, regardless of gender, age, race, or ethnicity.