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Sorry why fda said 300-3000?
It was 600 found it.
Q. What was motif bio phase 3 studies number?
Drug developers are free to ask for help from FDA at any point in the drug development process, including:
Pre-IND application, to review FDA guidance documents and get answers to questions that may help enhance their research
After Phase 2, to obtain guidance on the design of large Phase 3 studies
Any time during the process, to obtain an assessment of the IND application
Even though FDA offers extensive technical assistance, drug developers are not required to take FDA’s suggestions. As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design.
Phase 3 fda
Study Participants: 300 to 3,000 volunteers who have the disease or condition
Length of Study: 1 to 4 years
Jimzi,
I'm not sure this is about "finding" someone affected by expanding sample size but, instead, about using a sample size big enough to demonstrate the rarity of the said effect, perhaps to demonstrate that it is lower than 1 in 10,000. Since the rare effect will have a statistical distribution (Poisson probably) there are (rather arcane) statistical methods of calculating how large your sample should be before you can be, say, 99% confident that the illness is in fact rare. You are right in that, as the illness is expected to be rarer, the necessary sample size would increase, but not in the way you suggest.
To me the FDA has said to MTFB, you can't prove there is no dili as your trial size not big enough to statistically cover 1 in 10,000.
I must be wrong cause if I'm right you need 10,000 in your trial.
Someone - esp from MTFB, must be able to summarise on one page what the problem is for intelligent but non medical peeps. Lift the veil of vagueness and spell it out so the market can digest it
Jimzi
I cant figure it out either, whats another P3 Trial going to prove?
Per new link posted today.
Most of the drugs withdrawn from the market for hepatotoxicity have caused death or
transplantation at frequencies in the range of =1 per 10,000, so that a single case of such an event
rarely would be found even if several thousand subjects were studied.
So it appears your very unlikely to pick it up in P3 - any company trial.
And is 1 in 10,000 bad.
That UN report says there are now 1m deaths from AB resistance. Perspective?
I can't get my head around any of it
new price