Some COVID clinical trials lacked diversity, female representation
Women were underrepresented in pandemic trials of antiviral treatments, and sponsors didn't recruit enough Black and Asian participants for human studies on COVID vaccines, a new JAMA analysis of more than 100 trials found.
Why it matters: Treatment regimens that are found to be effective in clinical trials can't be confidently applied to all populations when certain groups are not adequately represented, researchers said.
What they found: The researchers analyzed 122 clinical trial studies that included more than 176,000 participants conducted during the pandemic from October 2019 to February 2022.
- Women were underrepresented in studies of drugs used to treat people hospitalized with the virus.
- Women are often underrepresented in trials due to the potential risk for fertility or pregnancy impacts. But they might have been shut out during the pandemic because they were not getting as sick as men.
- "There was a systematic pattern whereby men tended to be more sick and had worse morbidity from COVID-19, and that pattern probably influenced who was in the hospital and where treatment trials were recruiting from," Joseph Unger, study co-author and researcher Fred Hutchinson Cancer Center, told Axios.
- Asian and Black participants were underrepresented in prevention trials that primarily tested COVID vaccine candidates, but they were well-represented in treatment trials which were primarily conducted in hospitals during the pandemic.
The intrigue: Some diversity efforts yielded positive results: Hispanic and Latino participants were actually overrepresented in treatment trials.
- This is in part due to large clinical trial sites in California, Texas and Florida, study authors said, which have some of the largest Hispanic populations in the country.
- Designing trials in a way that can capture diverse patient groups helped in this case, the study authors conclude, to include Hispanic populations in results.
The bottom line: The analysis points to the need to improve diversity in clinical trials, particularly those not subject to National Institutes of Health mandates that require racial representation, the study authors conclude.
"Access to clinical trial sites is a big driver of participation," Unger said.