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Re: zebra4o1 post# 18330

Sunday, 06/22/2008 10:50:47 AM

Sunday, June 22, 2008 10:50:47 AM

Post# of 52052
Zebra, In his Roth presentation, Stoll said it has to do with RD-1 being a University based study (slower), using paper case report forms (also slower). RD-2 on the other hand was done by a CRO (faster), using electronic data capture (also faster).

Also, while RD-1 uses only a single dose level (1500 mg), there is also the crossover dosing a week later. And as Neuro suggested, since RD-1 is a University based study, one might expect more dropouts since these young subjects might be less reliable.

Fwiw, I've been thinking these RD trials might have a dropout problem generally, since there's ~ a week between the inital dosing and the crossover dosing. This gives the subjects the chance to think, do I really want to go through all that again, having to endure the multiple 'CO2 rebreathing into a bag for 5 minutes til you nearly pass out' routine? I don't know how much they pay these subjects, but participating in these trial means 2 days of unpleasantness. Perhaps getting a major buzz from the IV alfentanil might be some consolation however :o)
















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