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‘PACE-Gate’: When clinical trial evidence meets open data access

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Note: You can read the full article here.

By Keith J. Geraghty

Abstract

Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.

Source: Keith J Geraghty. ‘PACE-Gate’: When clinical trial evidence meets open data access. Published online before print November 1, 2016, doi: 10.1177/1359105316675213 J Health Psychol November 1, 2016 1359105316675213

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One thought on “‘PACE-Gate’: When clinical trial evidence meets open data access”

  1. dfwmom says:

    It is to be expected that some researchers will cut corners in order to achieve their goals. What is more disappointing is when the system designed to keep them honest, the process of publication and peer review, cuts corners — apparently deliberately. That should concern us all.

    That is why I blame PLOS and The Lancet for this failure, even more than I blame the researchers, themselves.

    When the system of peer-reviewed science fails, it means that science is not really science, and that medicine that is supposedly based on science… is not. So, when your doctor tells you that you have a clogged artery, and suggests surgery and a new device that did well in peer-reviewed trials, remember the PACE trial, and then consider an option that is at least 10 years old, so that you can see how reality compared to the trials. Based on what happened with the PACE trial, it is clear that we cannot trust medical trials or peer reviewed publications.

    Every medical professional and every patient should be concerned by the PACE trial, and the consequential erosion of trust in peer-reviewed science, because if we take the science out of medicine, then medicine is just another form of snake oil. You might as well go see your astrologist to find out how to treat your illness.

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