European regulators propose way forward for publication of full clinical trial data

European Medicines Agency (EMA)A group of European regulators have set out a way forward for the publication of the results of clinical trials of authorised medicines. 'Open clinical trial data for all? A view from regulators', published in the journal PLoS Medicine, responds to an article in the same issue by Doshi and colleagues, which calls for open access to all clinical-trial data so that independent re-analysis of medicines' benefits and risks can be conducted.

The response, 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.

The authors agree that 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 contrast, however, they warn 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.

The authors 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.

"We welcome debate on these issues," they remark, "and remain confident that satisfactory solutions can be found to make complete trials data available in a way that will be in the best interest of public health."

The full texts of the original article and the response are freely available on the PLoS Medicine website: