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Re: RBlatch post# 19124

Friday, 07/25/2008 6:08:14 PM

Friday, July 25, 2008 6:08:14 PM

Post# of 57984
Thanks Blatch. Based on Dr. Stoll's email, it sounds like we'll probably be getting the RD-1 and RD-2 results separately, with RD-2 coming first (the dose ranging study). The study he is referring to where the DSMB is helping in the data analysis is RD-2. RD-2 is using a CRO (RD-1 isn't using a CRO, but is University based).

If the CRO and the DSMB are still crunching data, I'm figuring that getting RD-2 results next week probably isn't likely, though perhaps the following week (?) Perhaps Neuro will have a better idea on an updated timeline.

Neuro - any ideas on why the CRO asked the DSMB for assistance ("It is clear that the CRO needed more assistance from the consultants on the DSMB in its analysis so they have asked for help")? Could this be due to ambiguities / complexities in the data, the unorthodox trial design, etc? I wonder how common it is for a DSMB to be involved in the analysis of clinical trial data? Thanks.













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