If the Norway Rituximab trials are a success - Will it be available worldwide?

Murph

Murph

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Murph said:
I'm overall an optimist, but I also like to follow good scientific practice in making predictions. So we should find a good background probability for establishing whether the Rituximab Phase III trial will report a success.

My reading suggests that in some fields, around 40 to 60 per cent of Phase III trials fail. (1, 2, 3)

View attachment 21754

Source: Clinical Development Success Rates 2006-2015

Rituximab is a Phase III trial so if we want to argue it is a higher chance of success than its peers, we need good reasons.

We can perhaps adjust our background probability for research coming from a stable European country, for researchers with no financial stake, and also for a disease with such strong Phase II trials. (Edit: some other good reasons to be more confident have been suggested below.) But there is no way the Ritux Phase III trial result unveiling is just a formality.

There remains a serious chance (perhaps 25 per cent?) that it comes back unable to reject the null hypothesis. I think it's important to keep this in mind so the patient community doesn't fall into despair if it happens - we have many irons in the fire at the moment and for once, not everything is riding on one research team or one study.
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I wrote this in a moment of objectivity but in reality, in my heart ,I had basically everything riding on this study. :'( I'm gutted to hear it found no difference between groups.
 
K

Kenny Banya

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Kenny Banya said:
It would be a massive surprise (as to be improbable) if the statistically significant response was in the placebo group
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Well, I eat my hat.
I have never heard of such a drug response rate in Phase II, to be statistically insignificant in Phase III

I can only hazard that the it was something to do with diagnostic criteria changes or a sub-group. It just doesn’t make sense.
 
Seven7

Seven7

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I never got an answer on the IVs in Cfs is not placebo since we do very well on IVs due to dysautonomia, so how did they adjust for that?
 
pibee

pibee

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lnester7 said:
I never got an answer on the IVs in Cfs is not placebo since we do very well on IVs due to dysautonomia, so how did they adjust for that?
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i was considering this when i got iv saline bc dehydatation and then iv ceftiaxone..One day later huge improvent
this would make sense if daily or weekly iv, but they got it only few times in a year right?
 
Seven7

Seven7

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pibee said:
i was considering this when i got iv saline bc dehydatation and then iv ceftiaxone..One day later huge improvent
this would make sense if daily or weekly iv, but they got it only few times in a year right?
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I was ending up on the ER about once a month for a few months, and the IV benefited me for around 3 weeks or so. I think it would balance my electrolytes or something. I got my issue resolved ( I used to have massive nausea that would not stop until I went to ER and got a shot and got dyhadrated from vomiting). Is all ok now ( that was a horrible symptom that I do not witch to come back).
But I guess the infusion might be some months apart. Still they have to see some increase on feelling good that might skew the results.
 
Gingergrrl

Gingergrrl

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I don't believe the fluid of the IV plays any role in my case b/c my last two doses of Rituximab were three months apart and any fluid would be long gone. In addition, I do not do well with IV fluids and got pulmonary edema from IV saline in 2014. I require an unbelievably slow infusion speed and NO extra saline or Dextrose in order to tolerate the infusion. So I am the one person who does better with less fluid. But this might not apply to anyone else.
 
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