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Female participation up in 2019 US clinical trials, but minority representation down

Published on 27/02/20 at 11:14am

The FDA’s Drugs Trials Snapshots 2019 report has been released, clarifying the demographic distribution of participants who were included in clinical trials for drugs that ultimately achieved approval over the past year.

In total, 48 new drugs were approved in the US throughout 2019, with trials for these products comprising 46,391 participants.

The studies were primarily for oncology products, with 11 such drugs approved over the time period, followed by six each in haematology and neurology and five each in sleeping disorders and psychiatry.  

Of this total number of participants, the highest proportion since 2015 were women at 72%, a figure driven primarily by the fact that six of the new drugs approved were for female-specific conditions such as breast cancer, postpartum depression, postmenopausal osteoporosis and hypoactive sexual desire disorder.

However, representation of minority ethnic groups fell slightly on last year’s statistics; last year the breakdown was 69% White, 14% Hispanic, 11% Black and 10% Asian. This year, the balance was 72% White, 18% Hispanic, 9% Black and 9% Asian.

Matt Fellows


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