Four years ago, the US National Institutes of Health (NIH) launched a pilot project to “leverage the social power of the internet to encourage constructive criticism and high quality discussions.” The service allowed readers to post signed comments below any of the 28 million citations indexed in PubMed and was democratically dubbed “Commons”. But earlier this month, […]
Kamal R Mahtani, Tom Jefferson, and Carl Heneghan reflect on the lack of definitions, and propose a solution […]
Revolving doors are used to facilitate entry or exit into a building. The trick with using these doors is always to get your timing right. Too fast or too slow and you get stuck. The analogy seems apposite for a brace of recent announcements of important pharmaceutical industry figures taking over parts of UK operations […]
On the 8 December the European Medicines Agency (EMA) and the EU Commission hosted a workshop to discuss Adaptive Pathways, formerly known as Adaptive Licensing. The 180 physical and 155 remote attendees included regulators, representatives of patients’ organisations, payers, academics, industry, and health technology assessment bodies. The aim of the meeting was ostensibly to discuss […]
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 everyone here and here and here. Briefly, the first phase of the policy sees the release of fundamental components of clinical study reports (CSRs) of randomised controlled trials […]
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 […]
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 […]
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 […]
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 […]
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 […]