- European regulators examined the reasons for and against the open access of the results of clinical trials - News about the European Union 2012-04-18


“The 'Open clinical trial data for all? A view from regulators', published in the journal PLoS Medicine and co-authored by the European Medicines Agency's Senior Medical Officer Hans-Georg Eichler, its Executive Director Guido Rasi, and three other European regulators, examines the reasons for and against the open access of these data. According to the authors, clinical-trial data should not be considered commercially confidential and that open access could also lead to public-health benefits through independent analysis and the development of predictive models. In March 2011, the EU Clinical Trials Register was launched by the European Medicines Agency (EMA). The publication responds to another article in the same issue also published in the journal PLoS Medicine.This article calls for open access to all clinical-trial data so that independent re-analysis of medicines' benefits and risks can be conducted. However, the response from the European regulators also warns that there is a risk of breaches of patient confidentiality in publication of full raw datasets. They also express their concerns that analysis by independent groups is not always equivalent to it being free of conflicts of interests and of high quality. In the publication, the European regulators conclude by arguing for the development of standards, both for protection of personal data and for meta-analyses and other types of confirmatory study, to overcome these risks. They also call for rules of engagement for sharing raw data, with the same standards applying to all clinical trial data on medicines, regardless of the type of sponsor.”



08/16/2012, 06:08

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Date tagged:

04/18/2012, 15:30

Date published:

04/12/2012, 17:38