'Why the dispute about PACE trial data matters to everyone.'


Queen Mary University of London are appealing an Information Commissioner decision that the data for the PACE trial should be released.

The Principal Investigators for that trial are also trying to claim that the PLOS One data-sharing regulations should not apply.

Since just about everything to do with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is disputed, it’s no surprise that there has been controversy surrounding the PACE trial from the start. But now this argument threatens to become much wider and drag in a large part of academic research, any study, in fact, in any field, that involves human participants.

The publicly funded PACE trial, published in 2011 in The Lancet, compared different interventions (Cognitive Behavioural Therapy, Graded Exercise Therapy, Adaptive Pacing Therapy and Specialist Medical Care) for ME/CFS. Since its inception the study has been criticized by patients, and after its publication they made a series of Freedom of Information requests for the data. The responsible research centre, Queen Mary University of London, has received 35 requests for 160 pieces of information. Many have been rejected, deemed vexatious, on the grounds that patients were waging a campaign to discredit the trial.

This dispute, largely until that point between patients and the investigators, escalated at the end of last year after a series of blog posts by David Tuller and the intervention of Professor James Coyne. Coyne, who has a long history of exposing and debunking pseudoscience, made his own request for the data from the publishers of a PACE follow-up study on the cost effectiveness of the interventions. This study was not in the Lancet but carried by PLOS One, which has a stated policy of data sharing. Coyne applied under the PLOS One regulations in force at the time of publication.

At first, Coyne was also told his request was being rejected as vexatious. This was clearly absurd: Coyne is well respected with an excellent reputation, indeed could be argued as having a bigger career reach than any of the trial investigators. It was then suggested that trial data could not be properly anonymized. This reason was in turn dropped: a sibling trial, FINE, had shared data, and the FOI commissioner recently ruled on another PACE request by patients that the data could be anonymized. Peter White, the most senior of the trial principal investigators (PIs), conceded in a recent letter to the Wall Street Journal that the data can be anonymized.
White now claims, as stated in the letter, that they must safeguard the data to protect the patients’ interests; they have a duty of care such that any request for data must be in the context of a defined research proposal deemed acceptable by institutional committee. It is this claim that, were it to succeed, would have a stifling effect on academic research in many fields. If any such claim were recognized, it would not just apply to this trial but be a precedent applied across disciplines to any studies involving human participants.

It must not be allowed to succeed.

It is also false.
Full text here.

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