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DonShimoda

10/29/10 9:44 AM

#3019 RE: BTH #3016

Why were the Phase 3 trials in everolimus and temsirolimus stopped then, at the interim?


News flash. Renal Cell Cancer is NOT sarcoma. You're making just another bogus argument.

exwannabe

10/29/10 10:01 AM

#3022 RE: BTH #3016

"Why were the Phase 3 trials in everolimus and temsirolimus stopped then, at the interim? "



Do you mean the RAD001 trial, it was well more than just stat sig:

"The primary endpoint of progression-free survival was increased from median 1.9 to 4.9 months (hazard ratio 0.33, P < 0.001) "

Then why did The Harv say (several times I might add), that based on the way the "trial is powered, there is a reasonable chance" it would be stopped at the 2nd Interim



Overly optimistic and a tad of a hype? Ask him.

glass_half_full

10/29/10 11:06 AM

#3027 RE: BTH #3016

Just because a trial is stat sig at an interim does not get it stopped





Why were the Phase 3 trials in everolimus and temsirolimus stopped then, at the interim?



I think there is a difference between
(1) statistically significant from the placebo arm
and
(2) unethical to continue the placebo arm.

Additionally, IIRC, the current trend is away from stopping trials early based on follow-on evidence that the arms in some stopped trials could have re-converged.

JMHO.