Report on the EMA Workshop on clinical trial data and transparency

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:

• Clinical trials
• Data access
• European Medicines Agency
• Data protection

Additional information

Notes on contributors

Susan Bhatti

Susan Bhatti has worked in regulatory affairs for over 15 years and spent the past 6 years in clinical research, where she is involved in setting up and obtaining approval for clinical studies throughout Europe. Discussions with Ethics Committees in connection with data collected during clinical trials and the need for adequate data protection for patients are part of her daily work.