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Jim Murray: The EU, transparency, and access to clinical trial results
How is the EU involved in transparency and access to clinical trial results? Many readers will know this already, but perhaps not all. For obvious reasons, health professionals have tended to focus on...
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Jim Murray: Will governments support transparency for clinical trials?
Criticism of EU law is often aimed at an amorphous “Brussels,” but in many cases member states are the problem—as with the proposal to revise the Clinical Trials Directive. The proposal envisages a...
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Jim Murray: Transparency may help to reduce the misselling of medicines
Greater transparency on clinical trial results would help reduce off-label promotion—the promotion of medicines for uses for which they have not been approved. Looking at the US since 2004, I compiled...
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Simon Wessely: The lost trial—a Christmas story
A long long time ago, well, 1995 if you are asking, I was part of a team running a randomised controlled trial. I was, and indeed still am, working in a general hospital as a liaison psychiatrist. Back...
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Jim Murray: New fronts in the struggle for transparency
The European Court of Justice has struck down and ordered a rehearing of the cases for an interim injunction to stop the European Medicines Agency’s new transparency policy on clinical trial results....
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Jim Murray: Abbvie withdraw case against European Medicines Agency
AbbVie have withdrawn their legal challenge against the release of certain company documents on Humira (adalimunab) by the EMA. This followed an offer by the agency to redact parts of the document...
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Jim Murray: Volte-face by the European Medicines Agency?
The European Medicines Agency (EMA) has recently published to a targeted audience final consultation draft papers on its new “proactive” transparency policy on clinical trial results. As reported,...
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Jim Murray: Policy making behind closed doors
Campaigning for transparency on clinical trial results at EU level is getting to be like playing snakes and ladders, and I’ve just spotted three snakes. I’ve been trying to “deconstruct” the EMA’s...
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Richard Lehman: The Medical Reformation
The Reformation that we know best began some time after the year 1500, but had its roots in a technological revolution, which took place 50 years earlier—the invention of the printing press. Then...
View ArticleThe BMJ Today: The dangers of anal sex, ensuring service redesign is evidence...
There are some topics that the British just don’t like to talk about, and bottoms, bowel habits, and anal sex fall firmly into that category—even when the conversation is with their GP. But these...
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Jim Murray: A surprising development in the case of InterMune vs the EMA
InterMune has withdrawn part of its legal challenge to stop the European Medicines Agency from disclosing certain documents, which relate to the medicine Esbriet (Pirfenidone). The company is still...
View ArticleTom Jefferson and Peter Doshi: EMA’s double U-turn on its Peeping Tom policy...
Yesterday’s announcement that the EMA Management Board may have adopted a less obstructive policy to releasing clinical trial data comes hard on the heels of widespread coverage (see here, here, here,...
View ArticleTom Jefferson: EMA’s release of regulatory data—trust but verify
The European Medicines Agency (EMA) has now released the final version of its policy on the prospective release of clinical reports of trials, which are submitted by sponsors to support marketing...
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Surayya Johar: Open Access Week—the next generation
Open Access Week, a global event now entering its eighth year and running from 20-6 October, is an opportunity for the academic and research community to continue to learn about the potential benefits...
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Gustav Nilsonne: Towards an ecosystem for open data
Have you ever tried to get your hands on data from somebody else’s scientific paper? I have, for a meta-analysis. In my experience it is a discouraging task. If data still exist at all, they are too...
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Khaled E Emam: Pseudonymous data is not anonymous data
Recently, efforts have been made to make health data more generally available for secondary purposes, including research. These include the recent policy announcements from the European Medicines...
View ArticleTom Jefferson and Peter Doshi: Thanksgiving special—menus needed at the EMA’s...
It’s hard to imagine a restaurant without a menu, a sheet where the fare is listed, where the ingredients are explained, and limitations are clearly labelled (“not for people with gluten intolerance,”...
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Carl Heneghan: Evidence based medicine on trial
Evidence based medicine (EBM) should form the foundation of effective clinical decision making; however, growing unrest—and an awful lot of criticism—suggests the evidence bit of EBM is increasingly...
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Khaled E Emam: Towards standards for anonymizing clinical trials data
Although we are still at the early stages, manufacturers are starting to make individual participant data (IPD) from their clinical trials available. One of the key issues that has to be addressed is...
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Khaled E Emam: What are the privacy concerns when sharing clinical trial data?
The principles developed by industry and the European Medicines Agency (EMA) have made it clear that protecting the privacy of individuals is a necessary part of any policy to share participant data...
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Khaled El Emam: Is it safe to anonymize data?
Recently an article was published in Science claiming that it is easy to re-identify credit card transaction data that has been anonymized. While this is not health data, the authors generalize their...
View ArticleTom Jefferson: The EMA revolution gathers pace
In October 2014, the European Medicines Agency (EMA) promulgated its policy 0070 on the release of regulatory data acquired and held in the course of its regulatory function. At the time, some of us...
View ArticleTom 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...
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...
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...
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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...
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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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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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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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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...
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...
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 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...
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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 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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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...
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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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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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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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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,...
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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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 ArticlePrecedent 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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