26 November 2012
Lord Marland, Parliamentary Under-Secretary of State, Department for Business, Innovation and Skills, has answered a House of Lords Question tabled by the Countess of Mar concerning the PACE trial.
The Countess of Mar (Crossbench):
To ask Her Majesty’s Government whether the refusal by researchers to publish trial data on recovery rates and positive outcome rates specified in their application for grant funding provided by the Department of Health, the Medical Research Council, the Scottish Office and the Department for Work and Pensions for “Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial” contravenes the agreement the researchers entered into when the award was made.[HL3151]
Lord Marland (Conservative):
The PACE trial: A Randomised Controlled Trial of CBT, graded exercise, adaptive pacing and usual medical care for the chronic fatigue syndrome, was funded by a Medical Research Council (MRC) grant to Queen Mary, University of London.
While the MRC strongly encourages the publication and dissemination of the findings of all MRC-funded research it does not require the publication of underlying research data. As an MRC grant, the study was subject to the RCUK (Research Council UK) and MRC terms and conditions; no additional requirements around publication were specified by the other funders of the study.
The findings of the PACE study have been reported in The Lancet, in March 2011 (published online in February 2011) and in PLOS ONE in August 2012.
These papers included the results of analyses of positive outcome rates.
The MRC is aware that Queen Mary University London received a request under the Freedom of Information Act relating to data on recovery rates and positive outcome rates which relates to an analysis initially planned by the investigators in the original protocol for the study and which was published in 2007. It is understood that the request was declined by the university as this originally planned analysis was superseded and therefore not undertaken during the study.