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​Health Research Authority on the PACE trial

February 07, 2019

Sir Jonathan Montgomery, Chair of the Health Research Authority, has written to the Science and Technology Select Committee to say that the HRA has “no regulatory concerns about the conduct of the PACE trial.”

The PACE trial (White et al, 2011) was a large-scale study of graded exercise therapy (GET) and cognitive behaviour therapy (CBT) which found that some people with mild or moderate M.E. experienced a small degree of improvement after undertaking CBT and GET. These findings continue to be challenged.

The committee published Sir Jonathan’s letter today as “Correspondence” on its Research Integrity inquiry publications page. In it, Sir Jonathan responds to three specific areas of concern about PACE, raised with him by Carol Monaghan MP at a Select Committee evidence session in January 2018, and to related correspondence received from M.E. advocates.

These areas are of concern are:

  • failure to comply with the standards relating to disclosure of conflicts of interest, including the involvement of the Department of Work and Pensions DWP as one of the trial funders
  • availability of data for secondary analysis
  • changes to eligibility criteria and outcome measures.

Additional issues with the quality of the PACE trial, including use of the Oxford diagnostic criteria for inclusion, are “not of regulatory concern,” says Sir Jonathan, adding that it “would not be appropriate for the HRA to seek to resolve these debates about the quality of the study. Discussion of the meaning and robustness of results is how science is expected to proceed.”

The letter highlights that the trial was co-designed with a patient group. This is a reference to two of Action for M.E.’s previous Chief Executives (prior to 2011) serving as independent members of the Trial Steering Committee, and sitting on the Trial Management Group.

In a statement last August, our current Chief Executive, Sonya Chowdhury, explained that neither she nor the current Board of Trustees would agree to be involved in this way now, as reflected by our current biomedical research strategy. She said: “I am sorry that the charity did not advocate for this considerable level of funding to be invested in biomedical research instead. It was never our intention to contribute to any stigma or misunderstanding about the illness and I sincerely apologise to those who feel that, in not speaking out sooner and more strongly, we have caused harm.”

Given the HRA’s specific remit, it’s not unexpected that the letter makes no comment on the reliability of the PACE trial’s results, or how these results are interpreted by clinicians working with people with M.E. and/or CFS.

Our view remains that, while potentially moderately helpful for a minority of people with M.E. and/or CFS, these treatments are not effective or safe for everyone. We do not support the current NICE guideline’s view that CBT and GET “are the interventions for which there is the clearest research evidence of benefit” for people with mild to moderate M.E., given the legitimate questions raised about their safety and effectiveness.