Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS (ResetME) - Haukeland University Hospital

EndME said:
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.
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I think F&M is the team that would get the most value for money regardless of what it’s used for, so I have no reservations about trying to give them more than the budget.

I think this highlights why specialist clinics tied to researchers are important. If they already had access to hundreds of patients that were pre-cleared it would go a lot faster. And they would have access to more competence that could be hired for helping with the trials.
 
Sasha said:
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.
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I think there's probably already someone doing that for them (I doubt they'll be spending their time with R, Python or whatever). But I agree, these are the type of things were some extra money could probably be helpful.
 
Sasha said:
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.
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I was thinking about the lab work as well. There are lots of samples to analyse, and then there’s the statistical work as well.

They have some good people that has done the statistical stuff on previous papers (e.g. Hoel). If they are available and not already involved they might be able to contribute later on.

Although we’ve seen time and time again here how so-called experts get things wrong. So I’m more inclined to let them use the team they know and trust even if it takes a bit longer.
 
Sasha said:
@Jonathan Edwards - Given your trial experience, can you see any way that ResetME could be sped up? Including if it got extra money?
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I think you're gonna get a lot more value for money for other things than forcefully trying to speed things up, that from all we know, are already very quick and where we have no idea about current processes.

I think we've seen some renewed interest in studying B-cell markers here on S4ME. One of the big problems in ME/CFS research is having access to a meaningful cohort. If someone was to collect additional funding to take some additional samples for additional analysis, storage ect to look at some of these markers or whatever else might be of interest, especially before and after dosing in the trial, I'd think you'd get a lot more value for money.
 
EndME said:
I think you're gonna get a lot more value for money for other things than forcefully trying to speed things up, that from all we know, are already very quick and where we have no idea about current processes.

I think we've seen some renewed interest in studying B-cell markers here on S4ME. One of the big problems in ME/CFS research is having access to a meaningful cohort. If someone was to collect additional funding to take some additional samples for additional analysis, storage ect to look at some of these markers or whatever else might be of interest, especially before and after dosing in the trial, I'd think you'd get a lot more value for money.
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I agree, that's a really interesting idea - I'd like us to be putting those ideas to Haukeland because they're in the best position to know whether they need more money to speed up and how to weigh that against some extra potentially very interesting analyses.
 
EndME said:
I think we've seen some renewed interest in studying B-cell markers here on S4ME. One of the big problems in ME/CFS research is having access to a meaningful cohort. If someone was to collect additional funding to take some additional samples for additional analysis, storage ect to look at some of these markers or whatever else might be of interest, especially before and after dosing in the trial, I'd think you'd get a lot more value for money.
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I agree too, this is a really good idea.

Agreed @Sasha, it would be good to talk to Haukeland about their perspective on all of this. I'm not up to it myself atm unfortunately.
 
Sasha said:
Speed is absolutely of the essence
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Doing this properly is essential.

I get everyone’s desire for speed, I really do, I want (need) results and treatments ASAP. But most important is that they do this right.

This team have trust from people because they know what they’re doing and do things properly. They have set a timetable out for that. I’m not sure what any of us gain by speculating how quickly it could be done.
 
Utsikt said:
If you had a ton of money you’d only have two: quality and speed. The costs would be through the roof..
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Well, could have. RECOVER is a good example of how a lack of motivation and decades of institutional sabotage can turn a lot of money into a bunch of nothing. Motivation matters more than the rest, it turns out, or at least it's a necessary condition.

Not quality, not even quantity. How many RECOVER studies have even published so far? 4-5? Nothing worth writing about, not even half as much as the typical output out of ME/CFS research. Almost all of the research published so far on LC has been junk behavioral fishing expeditions or the usual useless rehab they keep pushing.
 
hotblack said:
Doing this properly is essential.

I get everyone’s desire for speed, I really do, I want (need) results and treatments ASAP. But most important is that they do this right.
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Totally agree that doing this properly is essential, but it's entirely possible that additional resources would allow the trial to be done both properly and faster. No one here, especially not me, is arguing that we should ditch quality for speed. I just want us to be sure that reasonable avenues for speeding things up will be considered. It may be that Haukeland have underestimated how much money they could pull in, and if they get a surplus, there may be ways to move faster, while maintaining quality.
hotblack said:
This team have trust from people because they know what they’re doing and do things properly. They have set a timetable out for that. I’m not sure what any of us gain by speculating how quickly it could be done.
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This whole forum is one big speculation-fest! :) I think constructive speculation can be helpful if it comes up with some good ideas. I'd rather start some speculation off if it has a chance of helping rather than stay quiet and possibly let a great opportunity pass by.
 
Sasha said:
This whole forum is one big speculation-fest! :)
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True :) And I really like the constructive attitude you’re describing and are approaching this with. At the same time I’d hate for anyone to get their hopes up and end up being disappointed if things just take as long as they have said it will take. So just wanted to drop that in here.

I’ll be quiet now and let you resume speculating. While I do some other speculating!
 
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