Is it time for T cell targeting clinical trials in ME/CFS?

V.R.T. said:
I just don't know how you could be any more meticulous about trial design without any lab markers/biomarkers to go off without adding a control group right off the bat, which I was informed a month or so ago isn't feasible or desirable.
Click to expand...
The trial design has already been re-worked based on a failed trial. There's no reason for that to be the end of the line.

There's room for a whole range of possibilities. Some have been discussed here and in other threads, some might require a different infrastructure (like patient registries), one might have to be stricter in ruling out other diagnoses pre-trial start, some insights might come from other epidemiological studies or long-term activity tracking studies, some might require re-analysing the "failed" data and seeing what is says or coming up with one or 2 new ideas. To some degree it is of course slightly arbitrary and anybody can only be proven right in the end once a trial succeeds.
 
Last edited:
Kitty said:
Do you mean drug failed? I don't see that as a problem, it's the result you'd expect more often than not.
Click to expand...
And it will of course always fail if the drug is not actually effective, for which the chances are probably quite high in general, especially in illnesses where the problem is completely unknown. The question is more so around how you can try to optimise your chances of the unblinded one being more indicative of efficacy even if a properly blinded one will always still be required afterwards.

I do think prioritising patient registries type scenarios might be one way to go.
 
Last edited:
EndME said:
I do think prioritising patient registries might be one way to go.
Click to expand...

It needs significant resources to keep them up to date, and they don't guarantee better cohort selection.

Even when participants are approached via hospital consultants who know a lot about their disease presentation and history, they still have to go through specific screening each time. Every trial asks a different question.
 
My imagination might be failing me, but apart from differentiating between types of onset, age, gender, severity, and duration of illness, I can’t think of anything that would increase the chance of an unblinded pilot being more indicative of the true effectiveness of the drug, that wouldn’t require substantial investments and time.

It would be great to have more resources to help, but I don’t think it should be prioritised over doing trials with what we have now. Rather, it should be done in addition to doing trials based on sound rationales.
 
In all seriousness though, It might be worth thinking about who could do this sort of trial in the UK.

Perhaps people who are not currently in the field, but who could be coaxed in with the genetics or further evidence if it emerges.

Can we think of anyone currently doing ME or LC research who would be well placed?

Outside the UK, is there anyone with the appropriate specialisation on e.g. Fluge and Mella's research team or Scheibenbogens?
 
V.R.T. said:
Can we think of anyone currently doing ME or LC research who would be well placed?
Click to expand...

You need someone completely focused on the problem who also has an ability to assimilate a whole range of material of relevance from various fields and balance all arguments for and against all the options. Nobody off the peg. Oystein Fluge has those skills. And he is humble with it, which helps.

There is nobody in the UK at present. But I have managed to get Michael Zandi interested and he ran with the use of B cell targeting for autoimmune encephalopathy. He is part of a team with interest in Long Covid at Queen Square. They have an MEA grant to look at ME/CFS. I think it is possible that a clinician at Queen Square would take this on. Either Mike or a colleague. But it has to be someone totally committed not just to getting an answer but to all the fall out. It will take a bit of tie but I am encouraged that things are moving forward.
 
You must log in or register to reply here.
Back
Top Bottom