The U.S. Food and Drug Administration is approving more novel pharmaceutical drugs based on single clinical trials and with less public disclosure about those trials than was the norm just a few years ago, a pair of recent studies from Oregon State University has found.
instead of clinical outcomes in certain cases. Surrogate markers are used as substitutes when the direct clinical outcomes take a long time to study, and they should be related to the clinical outcomes.
enables the drug to move through the approval process more quickly. However, reduced blood pressure does not assure reduced risk of death from heart disease, she said., reviewed FDA approvals for novel drugs in in 2017 and 2022 to determine how many trials were used to evaluate each drug prior to receiving approval from the FDA.
Of the 37 drugs approved by the FDA in 2022, 24 were approved based on a single study. Four of the 37 drugs reported three or more studies before approval. Roughly half of the 413 studies available for analysis were classified as randomized, while results were publicly posted on ClinicalTrials.gov for only 103 of the 413 studies.
That doesn't necessarily mean the FDA is denied access to those full results, Irvin said, but the public cannot read the results until they are posted publicly.
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