MRC supports the PACE trial & promotes data sharing
On 27th August 2018 the Medical Research Council (MRC) responded to the online article in the Times, which reported the call for a review of the PACE trial. The following day the MRC published a more detailed reply to the claims that the scientific evidence provided by the PACE trial for using CBT and GET in the treatment of CFS/ME is fundamentally unsound.
As funders of the trial, we reject that view: the PACE trial was funded
following expert peer review, was overseen by an independent steering
committee, and its published findings were also independently peer
reviewed. The process through which PACE was funded, supervised and
published therefore meets international standards for clinical trials…
Making the data available
One criticism of the PACE trial has been that the data is not widely
available to other researchers for use in further research and to
confirm the reproducibility of results. The MRC strongly supports the
sharing of data from clinical trials but it is critical that sensitive
personal information from study participants is not released when study
data is shared. We are currently supporting the PACE trial investigators
to anonymise the study data from over 600 participants so that it can be
made available to other researchers in a way that protects the privacy
of those patients who took part.
The MRC has recently started (with other research funders) a pilot of a
new facility for academic researchers to share data via the Clinical
Study Data Requestopens in new window (CSDR) web portal. We hope to
include the PACE trial on the CSDR portal within the next 6-12 months.
This will allow researchers to apply to the CSDR Independent Review
Panel to gain access to the dataset for their own analyses.
The statement goes on to invite researchers to apply for funding into the biological mechanisms underlying CFS/ME and gives its support to the UK CFS/ME Research Collaborative (CMRC).