From the Journal of Health Psychology, 1 November 2016 (open access)
‘PACE-Gate’: When clinical trial evidence meets open data access
Keith J Geraghty
Centre for Primary Care, The University of Manchester, 7th Floor, Williamson Building, Oxford Road, Manchester M13 9PL, UK. Email: keith.geraghty@manchester.ac.uk
Abstract
Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy.
Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement.
In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.
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