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 […]
Open data
Tom 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, […]
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 […]
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 […]
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 […]
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 part of […]
Tom Jefferson and Peter Doshi: Thanksgiving special—menus needed at the EMA’s restaurant
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 […]
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 Agency (EMA) on […]
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 […]
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 […]