Thank you for your last response. More questions if you have the time:
1. My question was confusing since it ultimately asked about statistical significance, and meant to ask concerning the chances that at the interim, Vital 1 would be below a p value of 0.01.What would be the difference in the two (p= 001, p=0.05) at the Interim? Chance of statistical significance of 0.04 at the final? From your answer, I am assuming that depending on curve shapes, etc, that percent power represents the chances or probability of both the treatment effect happening and being detected. Is that accurate? (It appears that Dr. Small was involved in both actual vs, the Halabi projected median survivals in both of CEGE's two GVAX Ph2 trials as well as the Provenge 9901 trial)
2. DNDN has reported that the diagnostic factors present at randomization in the recently enrolled 500 patient 9902b trial when used with the Halabi nomogram yield a projected median survival of 21.4 months compared to 20.4 months for 9901 trial. Dr. Small reported that the actual survival in 9901 was 5.8 months longer than the predicted survival. The HR and p value (Kaplan Meier)for the integrated 9901 and 9902a clinical trials, which had a total of 164 deaths were respectively 1.5 and 0.011. Assuming the treatment effect for 9902b is 5.8 months (using Dr, Small's Halabi numbers) and 180 events needed for the interim and 360 events needed for the final, what are the chances of Provenge bettering a assumed alpha of 0.01 at the interim? Statistical significance of 0.05 at the interim? Statistical significance of 0.04 at the final look?
TIA for your assistance and comments.
