The US Food and Drug Administration (FDA) released the ‘Drugs Trials Snapshots’ report for 2019, an overview of the demographic characteristics of participants in clinical trials for drugs that gained approval by the regulatory agency during the past year.
According to the release, 2019 saw 48 novel drug products receiving approval, either under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs), with a total of 46,391 patients participating in clinical trials to support the efficacy and safety of these products.
In terms of therapeutic areas, the drugs approved were mainly intended to treat conditions in areas including oncology (11), hematology (6), neurology (6), and psychiatry and sleep disorders (5).
Out of the clinical trial participants, 72% were women, with this figure being the highest compared to respective figures of Snapshots back to 2015.
The increased participation of women can be explained when breaking down the indications of the drugs approved. Specifically, developers of six new drugs approved during the past year conducted female-only clinical trials. These were for indications including breast cancer; postmenopausal osteoporosis; detection of fallopian tubes patency in women with infertility; hypoactive sexual desire disorder; and postpartum depression.
Other demographic characteristics presented in the report regard the patients’ ethnic groups, with 72% of the participants being White, 9% Black or African American, 9% Asian, and 18% Hispanic.
These figures show decreased ethnic diversity compared to last year’s approved drugs’ clinical trials, which included 69% White participants, 11% Black or African American, 10% Asian and 14% Hispanic.
Asked to comment on the newly released figures, a spokesperson for the FDA’s Center of Drug Evaluation and Research (CDER) told us that “there is significant variability in indications for which the drugs are approved from year to year and consequently trial populations will vary.”
“For example, the years in which multiple drugs are approved for sex specific indications (e.g. breast or prostate cancer) will show increase in respective sex participation. Similarly, large number of approvals for rare diseases (common in younger populations) will show a decrease in overall geriatric populations, but also less variability in racial or ethnic participation,” they noted, drawing attention to avoid ‘misleading comparisons’.
The importance of increasing diversity in clinical research, so as to prove efficacy and safety of products intended to treat general patient populations, was recently highlighted by industry experts during a webinar held by Outsourcing-Pharma - which is available on demand - titled Clinical Trials in Special Patient Populations.
Notable is, however, that the FDA has previously released a draft guidance encouraging male participation in clinical trials looking to treat breast cancer, suggesting that the incidence has increased by 26% during the past 25 years.