Statement from Queen Mary University of London (QMUL):
A Tribunal has concluded by a 2:1 majority that certain PACE trial data should be disclosed to a member of the public under the Freedom of Information Act.
The PACE trial was carried out according to the regulatory framework for UK clinical trials, which aims to ensure that trial participants can be confident that their information is only ever used according to their consent, and that their data is only shared under obligations of strict confidentiality. The outcomes were subject to the usual standards of peer review for published scientific research.
QMUL’s appeal against the Information Commissioner argued in favour of controlled and confidential access to patient data from the PACE trial in accordance with established policy and practice in medical research. QMUL had previously shared data from the PACE trial with other researchers only when there was a confidentiality agreement in place and an agreed pre-specified statistical plan for data analysis.
In complying with the Tribunal’s decision, we remain mindful of the interests of trial participants and acknowledge the assurance given by the Tribunal that participants will be adequately protected from personal identification by the disclosure of this information. No names or addresses of any participants have been released. We will continue to engage with other universities and bodies to debate the broader implications of the decision for clinical research.