Drugmakers should have to release complete trial data

04/11/2012 | New York Times (tiered subscription model), The

Drugmakers in the U.S. are not required to release full clinical trial reports to researchers or the public, and the FDA does not disclose the data that regulators review in the drug approval process. The result can be use of a drug based on incomplete data published in journal articles, potentially at great public expense, as in the case of Roche Holding's Tamiflu, write research fellow Peter Doshi and epidemiologist Tom Jefferson. The European Medicines Agency intends to release clinical study data after regulators review a manufacturer’s application, and the FDA should follow suit, the scientists argue.

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