Dear Leona Aglukkaq: Researchers write the health minister on clinical trials –

A number of opinions on the Canadian government’s proposed web-based registry to clinical trails. The main point of contention is whether transparency only applies to successful trials, or to all trials, successful or not. Following commentary by Matthew Herder of Dalhousie University provides one of the better elaborations on the issues involved in making transparency meaningful:

This is not to say that institutionalizing transparency is easy stuff. As commentators have pointed out transparency is not a truism. Yet governments, courts, media, and critics alike tend to frame it as a self-evident principle, typically quoting Louis Brandeis’ famous line “sunlight is said to be the best of disinfectants.”

Operationalizing transparency requires answers to a number of substantive questions, including: Why should something be transparent? What exactly should be transparent? When should something be transparent? What should trigger transparency? What are the institutional mechanisms of transparency? Who are the audiences of transparency? What are the consequences of transparency, or of failing to comply with transparency requirements? What are the tradeoffs potentially associated with transparency?

These are the very questions that policy-makers and drug regulators in other jurisdictions have grappled with or continue to tackle. And that’s precisely why the minister’s announcement is so disappointing. It demonstrated little interest in grappling with these critical policy questions, and no attention to what policy-makers are doing elsewhere.

It’s time Canada moved beyond paying lip service to transparency, and got serious about figuring out what that entails in the context of regulating medicines.

Dear Leona Aglukkaq: Researchers write the health minister on clinical trials – Science-ish –

And the response by Health Canada officials (spoiler alert, not that reassuring):

Health Canada responds to questions about hidden clinical trial data


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