comprehensive
The Food and Drug Administration is poised to tell drug and medical device makers how to better include people of color in the clinical trials that test whether products work and are safe, an agency official said Wednesday. Those guidelines are five months late.
To ensure that drugs work for everyone, they must be tested on a representative sample of people. But researchers have found that many clinical trials exclude the people of color who are often most affected by the diseases that drugs treat.
advertisement
To help fix that problem, Congress passed a law requiring companies to give the FDA their plans for diversifying clinical trials. As part of that process, the agency was expected to issue guidance by the end of last year.
STAT+ Exclusive Story
Already have an account? Log in
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+.
Already have an account? Log in
Already have an account? Log in
Monthly
$39
Totals $468 per year
$39/month Get StartedTotals $468 per year
Starter
$30
for 3 months, then $39/month
$30 for 3 months Get StartedThen $39/month
Annual
$399
Save 15%
$399/year Get StartedSave 15%
11+ Users
Custom
Savings start at 25%!
Request A Quote Request A QuoteSavings start at 25%!
2-10 Users
$300
Annually per user
$300/year Get Started$300 Annually per user
View All Plans
Get unlimited access to award-winning journalism and exclusive events.
Subscribe Log InNext article： Duchenne breakthrough therapy leaves behind pioneering families
