The European Medicines Agency (EMA) is moving forward the debate over the transparency and publication of data from clinical studies, announcing a workshop in November to help the agency “define the modalities of proactive access to clinical-trial data, in a way that best serves patients and public health”.
The EMA says it is committed to the proactive publication of data from clinical studies, and to giving interested parties access to full datasets. Moreover, it does not consider clinical-trial data to be commercially confidential.
All the same, a number of “practical and policy issues need to be addressed before complex data sets can be made available”, the agency notes.
It wants to hear the views, interests and concerns of “a broad range of institutions, groups and individuals” at the workshop, scheduled for 22 November 2012 at the EMA’s headquarters in Canary Wharf, London.
Places will be limited to 150, though, and offered on a first-come-first-served basis. Registration is open until 31 October 2012 (expressions of interest should be sent to email@example.com).
Among the issues expected to be addressed at the workshop are:
• What level of data (e.g., aggregate, patient-level) should be made available, and in what format?
• What conditions need to be in place when data are made available to third parties?
• How can patient confidentiality be guaranteed?
• How can the highest possible standard of secondary data analysis be ensured, in the interests of public health?
Last April, officials from the EMA and national European regulatory agencies outlined their position on data transparency in an article for the open-access journal PloS Medicine.
While the regulators had some caveats about the practicalities and potential consequences of full disclosure, they agreed it was “neither desirable nor realistic to maintain the status quo” of clinical-trial data being available on a limited basis.