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 advised caution in accepting the policy at face value, although we recognised the great contribution that the policy and the EMA’s attitude […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklCategory: Open data
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 conclusions to all other human behavior data. Credit card transactions can, however, leak health information if the store is a pharmacy, for example. […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklKhaled 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 from clinical trials. But I often get asked: what are we protecting these participants from? In this short piece I will answer this […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklKhaled 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 how to deal with the privacy question. If clinical trial data are anonymized, then it can be shared without having to go […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklCarl 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 the problem, and not the solution. […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklTom 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 gluten intolerance,” for example). How would we know what to order without a menu? But when it comes to selecting documents on the safety and […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklKhaled 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 making clinical trials data available, industry efforts to do the same, as well as care.data in the UK. All of these are premised on being able […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklGustav 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 often kept under lock and key. Savage and Vickers tried to retrieve 10 datasets from papers published in PLoS […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklSurayya 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 of open access, to share what they’ve learned with colleagues, and to inspire wider participation in helping to make open access a […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklTom 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 authorisation applications (MAAs). The agency has said that it will—at a future date—determine how to release individual participant data (IPD). Scope The policy—to become effective from 1 January […]
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