The Health Research Authority (HRA) has concluded that the PACE trial of treatments for myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS) met all regulatory requirements of its day and exceeded transparency requirements when judged against contemporary expectations.
Last year, over a hundred academics, patient groups, lawyers and politicians signed an open letter to the Lancet calling on the journal to commission an independent reanalysis of the data from the PACE trial, which it published in 2011.
The trial showed that adding cognitive behavioural therapy and graded exercise therapy to usual specialist medical care moderately improved outcomes for people with ME/CFS, but that adding adaptive pacing therapy was of no benefit.
The signatories of the open letter, which included academics from University College London, the London School of Hygiene and Tropical Medicine, Harvard, Berkeley and Stanford, said the “major flaws” and “unacceptable methodological lapses”.
The HRA did not address whether the trial conclusions are right. Its role was to judge whether the trial was properly approved and conducted.
In a letter to the House of Commons Science and Technology Committee, Jonathan Montgomery, chair of the HRA, said: “We commend the investigators of PACE for recognising the importance of transparency by acting on good practice recommendations for publication on protocols and the statistical analysis plan even though they are not regulatory requirements.”