Statement: Disclosure of PACE trial data under the Freedom of Information Act

Statement from Queen Mary University of London (QMUL):

A Tribunal has now concluded by a 2:1 majority that certain PACE trial data should be disclosed 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.

QMUL’s appeal against the Information Commissioner argued in favour of controlled and confidential access to patient data from the PACE trial. QMUL has shared data from the PACE trial with other researchers only when there is a confidentiality agreement in place and an agreed pre-specified statistical plan for data analysis.

This has been a complex case and the Tribunal’s decision is lengthy. We are studying the decision carefully and considering our response, taking into account the interests of trial participants and the research community.