Biotech Values

[poorgradstudent]

gtop:

>To see this another way, pretend you are the executive in charge of designing the pivotal-trial program for company X. The FDA offers you two options for an SPA that assures approval of your drug if it meets the requirements set forth in the SPA; however, you must pre-select which of the two options to incorporate into the SPA:

1) Success in two identical trials with N patients each and a p-value threshold in each trial of 0.05.

2) Success in a single trial with N patients identical in design to the trials in option #1 except that the p-value threshold is 0.01.<

Where's the third and easiest choice? Run a survival trial and unblind at a single point like most other companies do, all the while keeping your p threshold at 0.05.