Last year I was invited to give evidence to the Science and Technology Committee’s inquiry on research integrity.
Shortly afterwards I wrote about the questions I’d received as part of this session, posed by MP Carol Monaghan, which related to conflicts of interest in health and social care research.
Carol asked me about the PACE trial, a large-scale study of treatments for people with Myalgic Encephalomyelitis (ME), sometimes known as Chronic Fatigue Syndrome (CFS) although there is an important research question about whether they are the same. The condition is very debilitating and we need to be able to do more to help. I am grateful to Carol and to the Committee for bringing this study to my attention in this forum. After I gave evidence, the HRA received further questions about the PACE trial from members of the public and patients also concerned about this study.
The Health Research Authority has since conducted a detailed assessment of the PACE trial. This work has taken a significant amount of time and resource, and today Norman Lamb, the Chair of the Committee, has published our letter to him, setting out the results of this assessment, on the Committee’s website.
Some concerns with the PACE trial that were brought to our attention are beyond the remit of the HRA as it is not the job of a regulator to interfere with proper scientific debates about the significance of published results. The study was first approved in 2007, many years before the organisation that exists today was formed, and it is important to judge researchers and ethics committee decisions against the standards of the time when they were made. However, we have taken the opportunity to identify things that may need to change. In particular, we have committed to do further work to clarify expectations in the area of conflicts of interest and to give clearer advice on the proper approach to making data available for further analysis.
Our assessment of the PACE study has taken place alongside a strategic investment of increased resource into our research transparency work. We know that we need to be clearer with researchers, funders and sponsors about our transparency requirements, something which we set out in our response to the Science and Technology Committee’s report last autumn.
This assessment marks the end of our work on the PACE trial, and we will now direct our effort into ensuring that a robust regulatory framework protects and promotes the interests of all patients in good quality health and social care research in the future.
Again, we are grateful to Carol Monaghan for raising with us her concerns about the PACE study. As I know our response to the Committee makes clear, research transparency is of utmost importance to the HRA, and we will continue to update you as our work in this area progresses.
Professor Sir Jonathan Montgomery, HRA Chair