24 May 2012
Baroness Wilcox has answered three questions asked by the Countess of Mar who asked Her Majesty's Government regarding PACE study.
Protocols for the PACE study
The Countess of Mar: Why the recovery statistics and other outcomes as defined in the published Protocol of the PACE (Pacing, graded Activity and Cognitive behaviour therapy: a randomised Evaluation) trial have not been published.[HL45]
Why the "normal range" for both PACE (Pacing, graded Activity and Cognitive behaviour therapy: a randomised Evaluation) trial primary outcome measures (fatigue and physical function) were re-defined so that it was possible for a participant to deteriorate on both measures during the course of the trial yet still fall within the chief principal investigator's "normal range"; and what impact they consider this re-definition to have had on the validity of the trial.[HL46]
Baroness Wilcox: "The PACE study was funded by a Medical Research Council (MRC) grant to Queen Mary, University of London. The Department of Health for England, the Chief Scientist Office in Scotland and the Department for Work and Pensions co-funded the trial; their contributions were paid via the MRC grant.
"As for all MRC-funded studies, it is the responsibility of the investigators and the relevant journals, guided by peer reviewers, to determine how findings are published and when.
"The investigators' first paper on the outcomes of the PACE study was published in The Lancet in March 2011. This includes descriptions of normal ranges and how they calculated. The MRC understands that further publications are planned, one of which will address the issue of recovery."
Funding for the PACE study
The Countess of Mar: What is the position of the Medical Research Council as co-funder of the PACE trial regarding the subsequent reliance by the National Institute for Health and Clinical Excellence and the Department for Work and Pensions on the outcome as reported in The Lancet.[HL47]
Baroness Wilcox: "The Medical Research Council (MRC) is an independent research funding body which receives its grant in aid from the Department for Business, Innovation and Skills. The selection of projects for funding is determined through peer review.
"The decision to fund the PACE trial, a randomised controlled trial of cognitive behavioural therapy (CBT), graded exercise, adaptive pacing and usual medical care for the chronic fatigue syndrome, was based on MRC's usual rigorous peer review process for clinical trials. The study aimed to evaluate treatments that were already in use, and for which there was insufficiently 22 May 2012 : Column WA47strong evidence to support their effectiveness. The MRC strongly supported this research and the publication of the findings.
"The MRC strongly supports the publication of the findings of all MRC funded research to advance medical research worldwide and to inform new therapies and treatments. The investigators' first paper on the finding of the PACE study, was published in The Lancet; Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial, P White et al, The Lancet, Volume 377, Issue 9768, Pages 823 - 836, 5 March 2011.
"The MRC does not have a position on how the outcome of MRC-funded studies are interpreted and used by regulators or policy makers although, as above, it supports prompt publication of its research findings so they are widely available to all potential users and to support evidence-based treatment of patients."
The PACE study
The Countess of Mar: Which disease or condition was being studied in the PACE trial that was co-funded by the Medical Research Council, the Department of Health, the Department for Work and Pensions and the Scottish Chief Scientist's Office, in the light of the statement made by the Chief Principal Investigator, Professor Peter White, that the PACE trial did not purport to be studying myalgic encephalomyelitis.[HL69]
Baroness Wilcox: "The PACE study was funded by a Medical Research Council (MRC) grant to Queen Mary, University of London, the principal investigator was Professor P White at QMUL, co-investigators were Professor T Chalder, King's College London, and Professor M Sharpe, University of Edinburgh. The Department of Health for England. the Chief Scientist Office in Scotland and the Department for Work and Pensions co-funded the trial; their contributions were paid via the MRC grant.
"The criteria for the PACE study were published in the trial protocol and are also addressed in the main findings published in The Lancet."
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