Countess of Mar

Questions for Written Answer

 

         To ask Her Majesty’s Government to confirm that it is necessary for a publicly funded trial to be properly registered in the ISRCTN (International Randomised Controlled Trial Number) Register; that this is a condition for publication in reputable journals and, if so, whether they are satisfied that the PACE (Pacing, graded Activity and Cognitive behaviour therapy: a standardised Evaluation) Trial registration ISRCTN54285094 is complete and includes records of all changes in procedure from the point of registration onwards.

         To ask Her Majesty’s Government which disease or condition was being studied in the PACE Trial that was co-funded by the Medical Research Council, the Department of Health for England and Wales, the Department for Work and Pensions and the Scottish Chief Scientist’s Office in light of the statement made by the Chief Principal Investigator, Professor Peter White, that the PACE Trial did not purport to be studying ME (a synonym for CFS/ME), when all the trial documentation, ethical approval and funding refer to CFS/ME.

         To ask Her Majesty’s Government when and why the PACE Trial sponsor was changed from the MRC Clinical Trials Unit to The Medical Research Council and then to the Queen Mary University of London (UK) and why these changes are not recorded in the ISRCTN Register and the sponsors are described in the Lancet: 2011, 5th March: 377:823-836 as the Medical Research Council, the Scottish Chief Scientist’s Office, the Department of Health for England and Wales and the Department for Work and Pensions.

         To ask Her Majesty’s Government why the recovery statistics and other outcomes as defined in the published Protocol of the PACE Trial have not been published in view of their importance to the funders and the public interest.

         To ask Her Majesty’s Government why the “normal range” for both PACE 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” .

         To ask Her Majesty’s Government, in the light of the non-conformity of the PACE Trial with ISRCTN Register requirements, what is the legal position of the Medical Research Council as co-funder 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.