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 disclose any clinical trial data which it calls “confidential business information.” Given our experience over the past few months, we think […]
Category: Open data
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 to share results and data at the required speed, which might have compromised the public health response. After the emergency, leading funders called for incentives […]
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 of systematically pooling data for meta-analysis and in this case demonstrating the clear benefit of corticosteroids in accelerating lung maturation in preterm babies. Systematic reviews […]
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 European Parliament. In the words of the current Ombudsman, Emily O’Reilly, the Ombudsman’s function “was born out of the […]
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Canadian news sources, including the CBC and the Toronto Star, reported on Dr Navindra Persaud’s success in securing unpublished data from Health Canada about the safety and effectiveness of Diclectin (a widely used treatment for nausea during pregnancy). To its credit, the country’s drug regulator handed him thousands of pages of data […]
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 original study of 275 adolescents with depression—Study 329—concluded “paroxetine is generally well tolerated and effective for major depression in adolescents.” Yet the 2015 reanalysis […]
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 details of its implementation. We were invited to join these ongoing consultations, and have previously reported on the debate here and here. We have been […]
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 data. Under a separate, new policy (policy 0070), the EMA will take an additional step and create a web based platform for sharing manufacturers’ clinical […]
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 0070 on prospective access to regulatory data. Readers should refer to my previous posts for the salient points of policy 0070. The latest meeting (like […]
Tom Jefferson: Are we ready for the EMA revolution?
After attending a webinar on the European Medicines Agency’s (EMA) new 0070 policy, which formalises the release of regulatory data held by the EMA, some of my earlier doubts have been addressed by what seems to be a general EMA commitment to openness (see my first blog on this webinar). For example, following a remark […]