search for: 056598en

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2006 Oct 04
0
[OT] Survival and Function as co-primary endpoints in clinical trials. How to simulate in R ?
...this is partly (widely ?) OT. Not sure where to ask, R is my favorite computer tool (no kidding) and there are plenty of knowledgable and helpful people on the list. Background: There are discussions among experts and regulatory authorities (cf guideline http://www.emea.europa.eu/pdfs/human/ewp/056598en.pdf) that, in for example Amyotrophic Lateral Sclerosis, a functional endpoint (respiratory function, muscular testing, rating scale) should be associated (co-primary, 2 primaries etc..) to survival in drug trials. My problem: I wish to illustrate that from my point of view and when you have a dru...