Even Five Years Postapproval, Many Drug Studies Remain Nonpublic

Authors urge greater transparency of study results for drugs approved by the FDA

By Lori Solomon HealthDay Reporter

FRIDAY, Sept. 1, 2023 (HealthDay News) — Only a fraction of evidence from completed studies is available publicly before drugs receive U.S. Food and Drug Administration approval, according to a study published in the August issue of Health Affairs Scholar.

Robert M. Kaplan, Ph.D., from Stanford University School of Medicine in California, and colleagues reviewed availability of results prior to and during the five years following each of the 46 novel drugs approved by the FDA in 2017.

The researchers found that the 46 drugs approved in 2017 were evaluated in 1,149 studies (range, two to 165 studies; mean, 24.98). Before approval, an average of 9.22 studies were started and 5.82 studies were completed. For 19 of the 46 approvals, a single trial justified approval. An average of 1.42 studies had results publicly posted prior to FDA approval. For nine of the approved drugs, no results were publicly reported before approval.

“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,” coauthor Veronica Irvin, Ph.D., M.P.H., from Oregon State University in Corvallis, said in a statement. “It doesn’t mean they wouldn’t get approved, but it means we’d have a more complete picture.”

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