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Re: randychub post# 1493

Monday, 03/15/2004 4:27:50 PM

Monday, March 15, 2004 4:27:50 PM

Post# of 257293
Re: Asthma competition and trial design:

Asthma is a highly-competitive market and is getting more so. This is one reason I have valued GENR’s share of the IL-9 program at only $80M on a present-value basis (#msg-1981262)

>> After a run-in period to verify dependence on inhaled corticosteroids, patients were randomized to receive daclizumab or placebo in a 3:1 ratio. <<

I like PDLI’s use of a “run in” period to filter out “bad” patients before randomizing the remaining patients to one of the two trial arms (active drug or placebo). I think this design should be used more often in disease settings where patients are likely to experience a strong placebo effect (e.g. CNS illnesses) or spontaneous improvement (e.g. respiratory diseases).

AMD is a disease where a “run in” period is probably not appropriate because patients rarely if ever improve without treatment and there is a clear-cut efficacy measure (visual acuity on the eye chart), which makes a strong placebo effect unlikely.


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