Medical Writing Medical Writing Around the World Report on the EMA Workshop on clinical trial data and transparency

Volume 22, Issue 2 - Medical Writing Around the World

Report on the EMA Workshop on clinical trial data and transparency

Author: Susan Bhatti

Abstract

Access to patient data gathered in clinical trials is a highly controversial and complex issue that needs to balance three aspects: the public right to transparency regarding data used to approve new medicines, protection of the data privacy rights of patients involved in the studies, and commercial confidentiality concerns of the trial sponsors. In response to an increasing number of formal complaints about restrictive practices in publicising clinical data, the European Medicines Agency has started an initiative to enable access to patient-level study data. In November 2012, they organised a workshop to bring the stakeholders together to discuss and establish the way forward.

Keywords: clincal trials, data access, European Medicines Agency, data protection
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References

  1. TRIPs Agreement: Agreement on Trade-Related Aspects of Intellectual Property Rights. The TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994. Available from: http://www.wto.org/

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