Canada’s Decision to Make Public More Clinical Trial Data Pressures FDA

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From NPR: “Last March, Canada’s department of health changed the way it handles the huge amount of data that companies submit when seeking approval for a new drug, biological treatment, or medical device — or a new use for an existing one. For the first time, Health Canada is making large chunks of this information publicly available after it approves or rejects applications.

Within 120 days of a decision, Health Canada will post clinical study reports on a new government online portal, starting with drugs that contain novel active ingredients and adding devices and other drugs over a four-year phase-in period. These company-generated documents, often running more than 1,000 pages, summarize the methods, goals, and results of clinical trials . . .

Canada’s move follows a similar policy enacted four years ago by the European Medicines Agency of the European Union. The U.S. Food and Drug Administration, on the other hand, continues to treat this information as confidential to companies and rarely makes it public.”

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