english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2013 Recap > Clinical Trials Regulation (amendment analysis): ignorance = harm! (5/2013)

Advancing healthcare policy

Advancing healthcare policy in Europe: a chronological recap of actions

A recap of actions in 2013
Clinical Trials Regulation (amendment analysis): ignorance = harm! (May 2013)

Brussels, 7 May 2013

A joint open letter by AIM, ISDB and MiEF urges Members of the European Parliament to support the inclusion of strong transparency provisions in the Clinical Trial Regulation that is currently being discussed, and to amend the confusing new definitions proposed by the EU Commission, including that of ‘Low-intervention’ clinical trials.

> Click here to download the joint open letter (pdf, 184 Ko)

In addition, a three-slide presentation explains the importance of comprehensive definitions of clinical trials, encompassing post-authorisation efficacy and safety studies (PAES), and to avoid turning European citizens into guinea pigs by failing to ask for prior consent.

> Click here to download the slideshow (pdf, 100 Ko)

©Prescrire May 2013