Study Finds Most 2022 Drug Approvals Used A Single Clinical Study

More than 60 percent of the drugs approved last year won their FDA nod on the basis of a single clinical trial that was conducted by the drug sponsor, a new analysis has determined.

The 21st Century Cures Act streamlined the clinical trials process, including easing the research requirements for drug approval. Manufacturers are apparently fully embracing the change, Robert Kaplan and colleagues wrote in JAMA Network Open.

“New drug approvals in 2022 appeared to be based on fewer studies than before passage of the 21st Century Cures Act,” wrote Kaplan of the Clinical Excellence Research Center, Stanford University, Calif. and co-authors. “We believe consumers deserve access to the full range of evidence for the drugs they are considering, not just from the selected studies released to the public.”

In 2016 — the year before the Act was passed — 55 percent of products were approved based on three or more studies, in comparison with 11 percent in 2022, the team said.

Read the study here.

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