February 6, 2019

expert reaction to letter from the HRA to Norman Lamb regarding the S&T Committee’s inquiry on Research Integrity and the PACE trial

Reactions to a letter from the Health Research Authority (HRA) to Norman Lamb MP on an inquiry into the PACE trial.

Prof Michael Sharpe, Professor of Psychological Medicine, University of Oxford, said:

“The PACE trial authors welcome the findings of the Health Research Authority (UK HRA) review of the ethics and transparency of the trial. Patients with chronic fatigue syndrome, and the healthcare professionals who look after them, can be reassured that the evidence provided by PACE that cognitive behaviour therapy and graded exercise therapy are helpful and safe treatments for Chronic Fatigue Syndrome (CFS) is based on sound science.”

Prof Malcolm Macleod, Professor of Neurology and Translational Neuroscience, University of Edinburgh, said:

“The detailed comments from the Health Research Authority show that the PACE trial was conducted to a high standard.

“No trial is perfect, and over time there are continual refinements in our expectations for study design, conduct, analysis and reporting. In 2009 Glasziou and Chalmers published a discussion of research waste, and in 2014 the Lancet series on Increasing Value and Reducing Waste in biomedical research went further, with more detailed recommendations; recruitment to the PACE trial began 4 years before the first of these publications. It is important that we continue to seek improvements in the way we do research, but that ambition does not devalue or invalidate the findings of previous research such as the PACE trial.”

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine (LSHTM), said:

“No randomised trial is perfect. Carrying out very good randomised trials is difficult and has been made more complex by layers of governance requirements, many (but not all) of which do help the quality and conduct of a trial. When people do not like the results of randomised trials, they are prone to attempt to find faults with them which would not be raised if they liked the results. The careful scrutiny by the Heath Research Authority of the processes and conduct of the PACE trial has essentially vindicated the investigators in terms of their conduct of that trial. Instead of falling below contemporary standards the findings indicate that “Our review suggests that the PACE trial exceeded expectations in its transparency when judged against contemporary expectations.”

“There are no doubt improvements that can be made, and some lessons can be learnt, but it is clear that politicians can be driven by stakeholders who do not like results and may make unfounded criticisms that can appear to have greater merit than exists in truth. This does not mean that there should be complacency, but it does suggest that current processes are protecting patients as both participants in a trial and as consumers of the results of trails, especially those conducted under the auspices of the Medical Research Council.”

All our previous output on this subject can be seen at this weblink: http://www.sciencemediacentre.org/tag/cfs-me/

Declared interests

Prof Michael Sharpe: Prof Michael Sharpe was an author on the PACE trial.

Prof Malcolm Macleod: MRM was an author of the Lancet Waste in Research Series

Prof Stephen Evans: I have neither competing nor conflicting interests in relation to this trial. I am and have been involved in trials conducted by public bodies as member and chair of Independent Trial Steering Committees and Data Monitoring Committees, but not in the area covered by the PACE trial.