General trial timelines

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notBrad

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Anyone know if there's a fairly standard timeline for trials as in "once funded, X months to recruit then X months to start, etc..."

I'm eligible for 2 trials once which starts very soon (Tirasemtiv) and one which is waiting on funding (NP001). If they were to overlap and I could only choose one it would be the NP001 but it's not concrete.

Thanks,
Brad
 
It historically is a number of months. Not only funding but getting IRB approval can be very lengthy. They are working on improving this by centralizing the process but I was told in August 2014 that there was going to be a retigabine trial
 
So looks like I'm going for the Tirasemtiv then. ;-)
 
Some prework in operations can precede funding, but the problem w/ Neuraltus is they are looking for a partner, and that definitely takes time. Are you talking about the NP001 Sutter Phase 2 study? That looks funded and initiating this year, but also small enough to maybe fill just off its own pts or region.
 
Don't know re: Sutter but will find out.
Thanks,
Brad
 
Spoke to Dr. Goslin and she's written Dr. Miller at Sutter about the expected start date. It looks like it might be further out than the press releases would lead one to believe.
 
Usually is...nothing wrong w/ jumping on the first train (tirasemtiv), philosophically since you have no basis to know whether you would/will respond better to one or the other, given dz heterogeneity if nothing else. Hypothetically could be used together one day.
 
True. Getting researcher contact info for Sutter now. Will weigh everything and go from there.
 
Steve has been chosen for the Tirasemtiv study. They called today and sent paperwork via email. Lots off paperwork. We are trying to figure out if he should do the study. We are thinking he should try it. He did not so well with the Rilizule. Had no patience with the stomach and tiredness that came with it. If the Tiramtiv has side effects I know he will stop using it and I don't want him to start and then not support the study by dropping out so will have to convince him to stay on it the first two trials weeks. After that its not for sure that he will be the random choice picked to take the Tirasemtiv so lots of thinking ahead over the weekend. I also need to learn more about the trials so far.
 
The abstracts for the previous studies are on line. Looks like no d/cs due to adverse events. In keeping with results so far that are mediocre (had to torture the data to keep the program going, but you do what you can with what's out there) without a threatening side effect profile. The compound affects the muscle directly so that makes sense. So the odds are that Steve would tolerate it.
 
The waiting is so damn frustrating.
It's in the news here that $46b of Medicare funding gets wasted on unnecessary tests. Wouldn't it be awesome if money like that didn't get wasted on hypochondriacs and spent where it's really needed?

All the best with the trials, Brad.
God bless, Janelle x
 
Agreed Janelle and thanks, I still haven't made a decision yet...
 
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