Precedent pushing practice: Canadian court orders release of unpublished...
Canada’s Federal Court has just rendered a milestone decision for clinical trial transparency. In the case of Peter Doshi v. Attorney General of Canada (yes, that’s one of us), Justice Sébastian...
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Richard Smith: A Big Brother future for science publishing?
There have been big changes in science publishing in the 25 years since the appearance of the internet, but at the same time science publishing is still dominated by journals, a 17th century invention....
View ArticleKamal R Mahtani, Tom Jefferson, and Carl Heneghan: What makes a systematic...
Kamal R Mahtani, Tom Jefferson, and Carl Heneghan reflect on the lack of definitions, and propose a solution Systematic reviews involve systematically searching for all available evidence, appraising...
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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,...
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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...
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Kamal R Mahtani: Using systematic reviews to reduce research waste—who really...
The global spend on biomedical research and development is about $250 billion, so why is so much of it still wasted, asks Mahtani The global spend on biomedical research and development is estimated to...
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Paul Glasziou and Iain Chalmers: Ill informed replications will increase our...
How does the replicability crisis relate to the estimated 85% waste in medical research? How does the “replicability crisis” relate to the estimated 85% waste in biomedical research? While both issues...
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Paul Glasziou: How to hide trial results in plain sight
Paul Glasziou discusses why trial results need to be better presented, so that readers can understand and act on the results. The AllTrials campaign rightly asks for “all trials registered; all results...
View ArticleTom 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...
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Chris Simms: The Iraq war, Chilcot, and cherry picking data: How to find a...
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...
View ArticlePharmaceutical 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...
View ArticlePeter Doshi, Matthew Herder, Tom Jefferson: Honouring Vanessa?
Health Canada seems to want to have it both ways: be seen as a regulator that serves the public interest through a progressive commitment to transparency, yet be trusted by industry to not publicly...
View ArticleLiz Allen: How Ebola and Zika might help to open up science
The Ebola and Zika epidemics could be the catalyst to open up and speed up the publishing of science. During the Ebola outbreak, there were examples of researchers being unwilling to share results and...
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Kamal R Mahtani on utilising systematic reviews: Is another trial necessary...
You don’t have to look too far to see the benefits of systematic reviews and their summary results. The well known Cochrane logo depicts a real example, highlighting the value of systematically pooling...
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Tom Jefferson: Happy birthday Ombudsman
The institution of the European Ombudsman celebrated its first 20 years of activity with a party for staff and all those who have and still are contributing to its work. The shindig was held in the...
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Diclectin data: Testing Canada’s new pharmaceutical transparency law
Earlier this month Canadian news sources, including the CBC and the Toronto Star, reported on Dr Navindra Persaud’s success in securing unpublished data from Health Canada about the safety and...
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Carl Heneghan: 329 trial restoration highlights need to restore public trust...
Fourteen years after a drug trial had been published, investigators —using multiple sources, including regulatory and legal documents—restored a version of the same trial and came to completely...
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The release of regulatory documents under EMA policy 0070: Now you see them,...
The European Medicines Agency (EMA) has issued its long anticipated new policy (policy 0070) on prospective access to clinical trial data, and is now in consultations to figure out the details of its...
View ArticleKhaled El Emam, Tom Jefferson, Peter Doshi: Maximizing the value of clinical...
In late 2010, the European Medicines Agency (EMA) became the first regulator in history to promulgate a freedom of information policy that covered the release of manufacturer submitted clinical trial...
View ArticleTom Jefferson: EMA confidential—the EMA continues consultation on its 0070...
Following on from its recent webinar I blogged about, the European Medicines Agency (EMA) held a consultation meeting with industry and selected stakeholders to discuss specific aspects of its policy...
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