In the light of last week's new paper out of Norway supporting the exciting results of the earlier RCT of rituximab for PWME, should US advocates be trying to get a US rituximab trial underway now?
On another thread, UK MEA medical advisor Dr Charles Shepherd (who has ME himself) said:
Interested in your thoughts about the US, @charles shepherd, @Jonathan Edwards, @Simon...
On another thread, UK MEA medical advisor Dr Charles Shepherd (who has ME himself) said:
charles shepherd said:If the large scale clinical trials are just left to the Norwegians, and let's assume that their phase 3 clinical trial produces some positive results in the summer 2017 when it finishes (which probably won't get published till 2018) this may help to get the drug made available in Norway.
But it won't mean that Rituximab will then get a product license here in the UK and NICE will recommend its use in ME/CFS
For this to happen, the UK regulatory authorities will require sound evidence of both safety and efficacy of Rituximab in ME/CFS from a number of high quality, preferably multicentre, phase 3 cinical trials
Phase 3 clinical trials are randomised controlled trials, like the one the Norwegians are currently setting up, and they are, not surprisingly, extremely costly to carry out.
If we don't start looking at how this could be done here in the UK - and it's interesting to note that the comments from Professor Simon Wessely in the New Scientist which suggest that he would also support this type of large clinical trial - then we are probably creating a situation whereby there is no real possibility of this drug becoming available for use in the UK for at least another five years.
I base this assumption on a scenario whereby we wait for the (hopefully positive) results of the phase 3 Norwegian trial in 2017/2018, then set about organising a phase 3 clinical trial here, and hope that others may follow suit.
This will take another 2 to 3 years to plan, set up, carry out, and analyse the results.
Which takes us up to 2021 or 2022...…
A long time to wait!
Having said that, the work on B cell status being carried out at UCL is very important and could help us to identify people with ME/CFS who are more likely/less likely to respond to Rituximab.
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But I do believe that we also need to making moves right now to try and get a large multicentre phase 3 clinical trial taking place here in the UK, just as is happening in Norway.
Which is why I will be raising this when the Board of the UK Research Collaborative meets at the MRC next week.
Because if we don't, it could well be a very long time before people with ME/CFS here in the UK, who could benefit from Rituximab, will have access to it.
Interested in your thoughts about the US, @charles shepherd, @Jonathan Edwards, @Simon...