I don't think we currently know. The NIH also had 500 people banging on the door for their study but only 20 ended up being eligible. Possibly Fluge and Mella also have other stuff to do. I think we're just gonna have to wait and see how quickly things can be done. The most important thing is not that things are done fast but rigorously and on that end we should be in safe hands with F&M.
Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS (ResetME) - Haukeland University Hospital
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V.R.T.
Senior Member (Voting Rights)
This is a very good question. Perhaps we could email the trial coordinator about it. I think her email is somewhere in the last few pages of this thread.
V.R.T.
Senior Member (Voting Rights)
I don't think this is a useful comparison. The NIH study was a deliberate foot dragging exercise run in part by someone whose goal was to prove ME was caused by thoughts and behaviours. There was a lot of criticism of the fact they only enrolled under 20 patients from such a big pool.
My limited own experience with ME/CFS clinics would tell me that you pretty much want Fluge and Mella alongside pretty much most of the recruitment/assessment processes in some capacity. There's no point in hiring people that are supposed to examine people when they have no idea what ME/CFS is supposed to be and don't believe in it.
It's not uncommon that a ME/CFS trial can be burdened by the fact that people part of enrolment processes don't believe the illness they are recuiting for even exists.
Utsikt
Senior Member (Voting Rights)
I don’t know. They indicated that the selection process is very resource intensive, and that they expect it to go through spring 2026.
The initial recruitment deadline was set to Dec 2026, and I would surprised if that doesn’t include a buffer to account for low uptake among participants. With so many interested, I wouldn’t be surprised if they get done earlier in 2026.
It takes a lot of time and they have to do it properly. There are probably few people that know enough about the clinical picture to do it properly as well.
We would not be doing ourselves any favours by rushing this process. We need a robust study.
I doubt it’s man hours in general, it’s probably man hours for key personell. You won’t be able to recruit that within a few months.
V.R.T.
Senior Member (Voting Rights)
Yes, but the main problem was that most people didn't meet the criteria of the study because the criteria were pretty rigorous. The criteria for the F&M study appear to also be somewhat strict as well. For example the NK condition could already cut a third of your pie away. No doubt they'll do their best to have it all finished asap and no doubt that time will come soon.
Sasha
Senior Member (Voting Rights)
Maybe, but maybe not. Fluge and Mella have been doing ME/CFS trials for years now and I'd have thought they might have brought some other clinicians on board by now.
We do need a robust study but if extra money would help hire in personnel (even trial managers rather than clinicians) to speed things up, we shouldn't miss the opportunity. Speed is absolutely of the essence.
V.R.T.
Senior Member (Voting Rights)
My point is that they seemed to have an overly rigorous criteria, perhaps to slow things down to a crawl as part of said foot dragging exercise. Which might sound conspiratorial but when you consider the history of ME at the NIH and the effort prefference nonsense they came up with...
Fluge and Mella might have rigorous criteria but I still dont think the NIH study is a good comparison.
V.R.T.
Senior Member (Voting Rights)
Agreed. If there is a way this can go faster without losing the standards of rigour that we need, we need to know and work towards it happening.
Whether the drug works or not, we need to know as soon as it is feasibly possible.
I think the amount of medical neglect we have faced makes us numb to the urgency of our situations.
But nobody here would suggest sacrificing scientific rigour for speed.
I don't think those points are actually well founded. The people that did the adjucation for the NIH study are all people that are generally viewed as well regarded: Lucinda Bateman, Andy Kogelnik, Anthony Komaroff, Benjamin Natelson, Daniel Peterson. They did not apply any overly rigorous criteria at all. They applied the necessary criteria. When I tried my best looking at the data, I didn't get the impression that anything went wrong in recruitment, it looked to me that everything went right even if there's only so much, or little, you can see in such data (most of what matters cannot be seen from data). One can argue whether the minimum illness duration or viral onset criteria were necessary, but that has nothing to do with rigor.
But that's anyways all a bit of a distraction and has nothing to do with the discussion for the F&M study. All I'm saying is that just because you have 300 people apply, doesn't mean the boxes are automatically going to fill up quickly. You might still have to end up doing a lot of thrawling. In their previous trials, F&M also had to throw out quite a few people for not fulfilling the criteria (when they got direct referrals for their study half didn't end up fulfilling the criterial, this time the number will be much larger). It will be the same this time. All of that takes time. It also took a year back then for half the amount of patients.
Utsikt
Senior Member (Voting Rights)
On a shoestring budget.
It’s completely unrealistic to hire someone now that would speed up the process of getting people to starting their treatments.
If this was a business situation they could hire some consultants at 5x the rate of a normal employee, but I don’t know of anyone providing those services for medical research in Bergen.
Quality, cost, speed. You can only pick two.
Kitty
Senior Member (Voting Rights)
They're probably working with a hospital that has quite a lot of other things to do as well; other people to look after whose needs are even more urgent.
They may also want to make their trial accessible, which means taking time to ensure severely ill people can take part in a way that doesn't leave them in a worse state.
I'd rather see thoroughness and inclusivity than haste. (Not that I think there's much risk of that, to be honest, they seem very good at sticking to their guns.)
Sasha
Senior Member (Voting Rights)
Doesn't mean that they weren't having interested colleagues getting involved. Maybe not, but we don't know.
Depends who they already know, who could be shuffled around in the hospital, and how you define 'now'.
You can have all three if you have a ton of money and the right connections. I'd rather we put forward ideas like this to the Haukeland team, in case any assumptions we make are too pessimistic because we lack inside knowledge.
Yes, I'm suprised to see that getting everybody enrolled within a year is somehow seen as slow, especially under this aspect. I don't really see how things could be faster in a sense that it would make any meaningful difference, but I think @Sasha very reasonably asks if there is something additional funding could help with, but I don't see why it would have to do with speed. I think there's much more interesting things additional funding could do (like taking certain additional tests of your participants).
Utsikt
Senior Member (Voting Rights)
If you had a ton of money you’d only have two: quality and speed. The costs would be through the roof..
V.R.T.
Senior Member (Voting Rights)
This
Utsikt
Senior Member (Voting Rights)
To make an impact on how soon the participants could be enrolled. The would need to fund and recruit someone today and hope they were up to speed already. The trial has already started.
I don’t think it’s realistic to speed up that part.
Maybe, just maybe we might be able to buy them some time for the analyses, and that would be far enough down the line to make recruitment possible.
I agree. Recruitment within a year is fast for ME/CFS standards, probably for any illness without a predefined cohort. I think faster than most things we've seen elsewhere. It's the same speed as their previous trial, for which they already had a cohort and only needed half the size. Cutting things by a handful of weeks really won't make a difference anyways.
But I do appreciate the question on whether there's things additional funding could help with. There probably are! I just don't think speed for recruitment is probably the most menaingful angle when things are already fast, but asking the team won't do any harm. Maybe they just need one additional hand for a thing here or there but that's nothing anybody on S4ME can answer.
Sasha
Senior Member (Voting Rights)
I didn't quite understand this point but that's interesting about the analyses. If we could buy them a statistician, it could speed up the writing of the paper once they've got the results.