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 […]
Open data
Peter 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 […]
Liz 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 […]
Kamal R Mahtani on utilising systematic reviews: Is another trial necessary or ethical?
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 […]
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. […]
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Canadian news sources, including the CBC and the Toronto Star, reported on Dr Navindra Persaud’s success in securing unpublished data from Health Canada about the safety and […]
Carl Heneghan: 329 trial restoration highlights need to restore public trust in trials
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 opposite conclusions. […]
The release of regulatory documents under EMA policy 0070: Now you see them, now you don’t
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 […]
Khaled El Emam, Tom Jefferson, Peter Doshi: Maximizing the value of clinical study reports
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 […]
Tom Jefferson: EMA confidential—the EMA continues consultation on its 0070 policy and concerns appear
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 […]