Transparency Versus Trade Secrets

Canada and Europe have stirred debate by opting to release clinical study reports underlying medical products approved or rejected by regulators.

The US has no such practice, treating this information as commercially sensitive. But some experts want American regulators to follow suit, arguing that transparency is key to understanding how regulators make their decisions and advancing guidelines on how products are used. It could also help catch regulators' errors.

And journal articles are no replacement for clinical reports. Only about half of clinical reports result in journal articles. They also include less data and are prone to bias, according to one analysis.


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