While clinical trial activity was strong in 2022 following a pandemic-induced dip, many trends resumed their pre-COVID trajectory—including plummeting diversity in clinical trials.
That’s right—despite recent efforts from the FDA, Big Pharmas, biotechs and sponsors alike, U.S. clinical trial diversity dropped to its lowest level of the decade, according to IQVIA’s report “Global Trends in R&D 2023.”
"We are certainly hopeful that we're in a period where the efforts that have been made in the last several years will begin to show up in terms of the completed trials where those results do get uploaded," Murray Aitken, executive director at the IQVIA Institute for Human Data Science, said during a March 29 presentation of the report.
On average, Black and Hispanic patient inclusion in mid- and late-stage clinical trials declined over the past decade without ever meeting levels proportional with national demographics. Black participant inclusion plummeted 46% in four years, with 81% of the U.S. Census demographic levels represented in clinical trials in 2018 compared to 43% in 2022.
Hispanic inclusiveness hasn’t declined as significantly, varying over the last 10 years but still never hitting representative levels. In 2022, Hispanic patients were enrolled in clinical studies at 53% of national demographic levels.
The story changes when looking at trials by therapeutic area. For example, Black patient enrollment was above U.S. demographic levels in psychiatry; hematology; infectious disease; allergy, immunology and rheumatology; and cardiovascular trials in 2022. Hispanic inclusion rates surpassed national demographic rates the same year for hepatology; infectious disease; allergy, immunology and rheumatology; and in respiratory conditions.
However, both Black and Hispanic patient representation were lowest in oncology, a space that accounts for 40% of trial starts—the indication with the most clinical trial activity for the year.
The large oncology presence plays a major role in the overall industry diversity drop, Nicole Connelly, Ph.D., research director of pharmaceutical R&D for IQVIA’s Institute for Human Data Science, said during the presentation.
“We've been able to obtain some good recommendations from FDA on how to operationalize diversity plans, but clearly there's still a lot of work to be done in this area,” Rachael Anatol, Ph.D., senior vice president of science and regulatory affairs at BIO, said on the same call. She emphasized the use of digital health tools and decentralized trials as key to improving diversity in the future.
Beyond the challenges with diversity, clinical trial activity as a whole was stable, with a 2% decline in non-COVID-19 trial starts compared to 2021 and an 8% increase in activity versus 2019. After enrollment hit an all-time high in 2021—around 4 million patients—it fell back down to 1.8 million in 2022, slightly above pre-pandemic levels.
While activity in many therapeutic areas returned to 2019 levels, trial starts in ophthalmology, women’s health and infectious disease met or surpassed 2021 levels. Also of note is a rise in depression trial starts, which were 68% higher than pre-pandemic levels, even though neurology trial activity dropped slightly since 2019.