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191025

Canada's Decision to Make Public More Clinical Trial Data Puts Pressure on FDA

"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. … Researchers who independently re-evaluate drugs say the reports are critical because the data they need is not readily available in medical journal articles. One analysis showed that only about half of clinical trials examined were written up in journals in a timely fashion and a third went unpublished. And when articles are published, they contain much less data than the reports. ... In addition, ‘journal articles emphasize benefits and underplay or, in some cases, even ignore harms’ that can be found in the clinical study report data.”

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