Joel Lexchin: Health Canada promises a new era in transparency

In March 2017 Health Canada released a discussion paper promising a new era in transparency. The agency committed itself to proactively releasing clinical trial data submitted by drug companies, similar to what the European Medicines Agency (EMA) is already doing and, again like the EMA, to processing applications for the same information for drugs already […]

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Simon Denegri: Is a better public debate about patient data on the horizon?

Few would argue that the public have been well served by the debate about how their data can support care and research now and in the future. After the shipwreck of care.data in 2014, efforts to communicate with the public have stalled. Indecision about the best way forward has gripped the medical research and healthcare […]

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Tom Jefferson: The EMA’s policy 0070 is live

Yesterday the European Medicines Agency’s (EMA’s) long awaited policy 0070 went live. I have previously described the policy, its aims, advantages, possible limitations, and potential impact on everyone here and here and here. Briefly, the first phase of the policy sees the release of fundamental components of clinical study reports (CSRs) of randomised controlled trials […]

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Chris​ Simms: The Iraq war, Chilcot, and cherry picking data: How to find a way forward?

The first week of July 2016 was a week to remember. A cluster of war related stories dominated the media, including the 100th anniversary of the Battle of the Somme (1 July), the death of Elie Weisel on 2 July, on 3 July there was the deadliest bombing in Bagdad since 2003, three days later we had the release […]

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Pharmaceutical transparency in Canada: Tired of talk

Health Canada has been talking about improving the transparency of information around pharmaceutical drugs for years. And for years the drug regulator has failed to back up that talk with commitment and action. The lack of transparency around pharmaceutical drugs continues to undermine patient safety and public health. Unless a drug’s full safety and effectiveness […]

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