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Even 5 Years Postapproval, Many Drug Studies Remain Nonpublic

(HealthDay News) — Only a fraction of evidence from completed studies is available publicly before drugs receive US Food and Drug Administration approval, according to a study published in Health Affairs Scholar.

Robert M. Kaplan, PhD, from Stanford University School of Medicine in California, and colleagues reviewed availability of results prior to and during the 5 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 1149 studies (range, 2 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 9 of the approved drugs, no results were publicly reported before approval.


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“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, PhD, MPH, 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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