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 found.
Researchers agree it is important to minimize delays in making treatments for diseases such as cancer available to patients, but they say their findings point to a need for greater transparency around how drugs receive approval.
As part of that law, the FDA relaxed some standards to allow treatments for priority health conditions such as cancer to be approved with fewer supporting studies, and placed less emphasis on randomized clinical trials, allowing pharmaceutical companies to rely on surrogate markers 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.
Related StoriesResearchers also looked at the availability of drug trial results on the public-facing ClinicalTrials.gov, a database maintained by the National Institutes of Health that patients can use to learn more about drugs they may be prescribed. 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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