EMA backs full access to trial data | InPharm

“The European Medicines Agency says it wants to open up access to full clinical trial data, but warns that some restrictions may need to remain. The EMA has been heavily criticised in recent years for not making full clinical trial data available to independent researchers, with the BMJ and the Cochrane Collaboration among its fiercest critics. The EMA maintains the EudraCT database, which contains full drug trial data on all approved drugs.  But EudraCT is not a public database, and the European Directive that created it states that it should be kept confidential. Until now the European regulator has argued that commercial confidentiality and patient confidentiality could be at risk if data was shared, but critics say that in many cases this is simply not the case. The EMA has now shifted its stance, saying trial data should not be considered commercially confidential.  A new article authored by EMA and national European regulators says authors say open access can benefit public health by allowing independent analysis and the development of predictive models, and say these benefits outweigh the need for pharma to keep its data secret. But it maintains that patient confidentiality could still be a risk, and wants to see standards agreed to guard against this problem. Writing in the PLoS medical journal, the Agency’s senior medical officer Hans-Georg Eichler, EMA executive director Guido Rasi, and three other European regulators, examines the reasons for and against the open access of these data. 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 new push for transparency is being led by new executive director Guido Rasi, who took up his post in November last year. The authors say that full clinical trial reports of authorised drugs should be made publicly available to enable independent re-analysis of drugs’ benefits and risks. They say that this should be published in a ‘raw’ form – meaning that the clinical trial reports should not just comprise the protocol, summary tables, and figures of studies, but the full raw data set, which includes data at the patient level. The EMA’s new approach has come after concerted pressure from independent groups wanting to access and analyse drug data. In June 2010 the European Ombudsman censured the EMA for not releasing data to the Nordic Cochrane Centre on obesity drugs. The regulator eventually handed over the requested information in February 2011. But they say that raw data should be published without any checks and balances, and warn that patient confidentiality could be compromised if full raw datasets are published. The regulators also stressed that analysis by independent groups is welcome, but their independence does not automatically mean their studies are free of conflicts of interests and of a high quality. Despite the regulator agreeing to greater openness in principle, it is not proposing immediate action. Instead the authors argue that the next step is for a new set of standards to be developed and agreed, both for protection of personal data and for meta-analyses and other types of confirmatory study. They also call for rules of engagement for sharing full data, with the same standards applying to all clinical trial data on medicines, regardless of the type of sponsor. This suggests that the views of the pharmaceutical industry and other groups will be sought before any plan is put in place.”