A recent Biden administration report on “significant” foreign barriers to U.S. exports suggests that a battle may be brewing over clinical trial transparency.
Late last month, the U.S. Trade Representative issued its latest annual look at foreign trade and, in a section devoted to the European Union, noted a European Medicines Agency policy toward disclosing clinical trial data is problematic. Specifically, the report referred to the “potential disclosure” of trade secrets in clinical study reports submitted by drug companies to the EMA for marketing approval.
Clinical study reports contain a wealth of information about clinical trial methods employed by pharmaceutical companies as well as patient data. These documents are reviewed — and widely relied on — by regulators worldwide when assessing whether new medicines are safe and effective before deciding whether to make them available to patients.
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