In the past year, Queen Mary University of London (QMUL) has declined two applications for access to data from the PACE trial, and is presently appealing against a ruling in favour of openness by the Information Commissioner. A recent statement by QMUL said that it was seeking further advice from various quarters on these decisions. In response to this invitation, ME Research UK has contacted the institution with its views before the appeal comes before the First-Tier Tribunal (Information Rights) in April 2016. As our charity has, over the past 15 years, funded more than 40 biomedical research projects on ME/CFS, mainly in the UK but also in Canada, Australia, Sweden and Belgium, it is ideally placed to comment on scientific issues arising in this field.
As we explained, the PACE trial has a controversial history – indeed, we have highlighted the limitations of its findings many times since publication in 2011, as well as the persistent over-hyping of the very modest trial results by the media. Aside from the historical controversy, however, we believe that there is a broader issue at stake, namely, the accessibility of scientific data, particularly publicly funded data. There has been a sea-change in attitudes and opinion in the scientific world in recent times, with a trajectory towards openness and accountability. The sharing of data is increasingly becoming the norm and access to research data more common, especially for government funded research. Indeed, the Medical Research Council provides detailed guidelines on the sharing of research data; its policy statement makes clear that the “overarching aim for data-sharing is to maximise the life-time value of research data assets for human health and to do so timely, responsibly, with as few restrictions as possible, in a way consistent with the law, regulation and recognised good practice” (read more). Given the dearth of biomedical research into ME/CFS compared with other chronic diseases of similar prevalence, it may be particularly important that “underlying data should be made freely available for researchers to use, wherever this is legal and ethical”, as is the policy of the open-access suite of PLOS journals (read more).
Our letter goes on to say that highly respected scientists inside and outside the field of ME/CFS have recently added their voices to the calls to make the PACE trial data available. In addition, Dr Richard Smith, former editor of the BMJ, has made his own views clear in a perspicacious piece: “…I know something about the emotion that surrounds chronic fatigue syndrome, but I still think that QMUL…and King’s College London are making a serious mistake in refusing to release the data behind a controversial trial of treatments…I fear that [they] are defending the indefensible and like King Canute failing to stop a tide that is coming in fast” (read more). Given the views of these and other professionals, and the trend towards open access to underlying data (particularly from clinical trials), ME Research UK recommended that QMUL release the anonymised data, whether under a data-sharing agreement as proposed by the Medical Research Council or by some other mechanism. Openness may, in fact, lead to real benefits, as some aspects of the data may have been under-explored or need further review; as the G8 communiqué on Open Data states, “Access to data allows individuals and organisations to develop new insights and innovations that can improve the lives of others” (read more).
In light of the principles of open access to scientific data, we hope that QMUL will contribute towards the enrichment of scientific knowledge by making available the data from the PACE trial.
