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Re: DewDiligence post# 34394

Monday, 09/25/2006 12:36:01 PM

Monday, September 25, 2006 12:36:01 PM

Post# of 252496
Re: Satraplatin (addendum)

GPCB’s Bernd Seizinger handled this trial smartly by maneuvering to delay the unblinding beyond the point where it was originally scheduled to occur. By so doing, he delayed crossovers from the control arm to the Satra arm and thereby improved the probability that Satra will eventually show a decent (although not necessarily statsig) benefit in overall survival.


I hope you are not saying that he delayed giving Satraplatin to placebo patients after progression to improve the chance of getting survival significance. This would be unethical to say the least and possibly illegal.

As the trial was event based and blinded, it would take some interesting intervention to have any influence on the time for unblinding. On the other hand, if the drug worked better than expected for the sample of patients, then a delay beyond projection would be natural. The DNDN's P11 trial may be going through this experience.

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