Most FDA-approved drugs in 2022 received only 1 clinical trial, OSU study says

PORTLAND, Ore. (KOIN) — Public health officials are approving newer pharmaceutical drugs after fewer clinical trials, according to researchers at Oregon State University.

Published in two peer-reviewed medical journals, the studies focused on how many clinical trials novel drugs received before the U.S. Food and Drug Administration approved them between 2016 and 2022.

Researchers found that 65% of FDA-approved drugs in 2022 underwent one clinical trial, compared to 20% in 2016. About 11% of the drugs approved in 2022 had at least three clinical trials.

Of the drugs that underwent several trials, drug companies were required to reveal just two of them on ClinicalTrials.gov — a National Library of Medicine platform that doctors and patients alike use to learn research study results.

According to OSU College of Health Associate Professor Veronica Irvin, only posting the results from two trials leaves out critical information for people who want to know the full scope of the studies.

“Everything is supposed to be transparent with this FDA process,” Irvin said in a statement. “The purpose of ClinicalTrials.gov was to have a way for the non-scientific community to access the trials and their results, in a way that people can understand."

OSU attributed the changes to the 21st Century Cures Act that was signed into law in December 2016. The Cures Act was passed in an effort to fast-track drug approval for patients with life-threatening diseases who can’t wait for the typical clinical trial period, which can take several years in some cases.

The university reports that many researchers approve of the act’s overall goal, but believe it should require more public disclosure.

“We’re not saying that cancer drugs need a lot more studies; just that they should show all the results or trials that are completed,” Irvin said. “It doesn’t mean they wouldn’t get approved, but it means we’d have a more complete picture.”