STAT+: U.S. Trade Rep report sparks concern that a new clash may occur over clinical trial transparency

"It is completely unacceptable for the U.S. government to be pressuring foreign democracies to hide data from their own citizens," one European researcher said of the U.S. Trade Rep report.

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.

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