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."