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 authorisation applications […]
Open data
Tom Jefferson and Peter Doshi: EMA’s double U-turn on its Peeping Tom policy for data release
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, […]
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InterMune has withdrawn part of its legal challenge to stop the European Medicines Agency from disclosing certain documents, which relate to the medicine Esbriet (Pirfenidone).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 looking for […]
The BMJ Today: The dangers of anal sex, ensuring service redesign is evidence based, and the EMA taken to task over data disclosure
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 […]
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 […]
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” […]
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, information published under […]
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AbbVie have withdrawn their legal challenge against the release of certain company documents on Humira (adalimunab) by the EMA.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 […]
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 […]
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 […]