Thursday, April 24, 2014 12:39:21 PM
"fda guidance adaptive clinical trials"
I don't think I've heard anyone discussing these guidelines on this board so I thought I would share the information. If I missed a post then my apologies. If this comes off as condescending or talking down to anyone then my apologies, especially to you "Top 20".
Along those same lines there are very good peer reviewed articles out there (some from the FDA) that go into great detail on the structure of adaptive design trials and the logistics. Here is one of particular interest to me that lays out the firewalls between the different entities:
Adaptive design clinical trials and trial logistics models in CNS drug development?
Sue-Jane Wang a,?, H.M. James Hung b, Robert O'Neill a
And another:
Adaptive design methods in clinical trials – a review
Shein-Chung Chow*1 and Mark Chang2
There are others as well.
I found some contradictions in the literature regarding sample size adjustment. The contradictions are around the use of blinded vs unblinded data to make the changes to sample size if needed. I've found that generally the view is that unblinded is more accurate and if an independent organization is used (I viewed that as a CRO (ISAC) or DMC) then the type I error can be controlled.
Here are some excerpts from the papers:
And also this:
AND this:
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