In order to understand the deemed importance and subsequent disappointment of the failed progesterone (Protect) clinical trial, note the agenda for Day One of the upcoming Traumatic Brain Injury conference:
8:15 - The Protect 111 Clinical Trial, is there a Path Forward
8:35 - A Global Trial of Progesterone in TBI: Outcomes and Lessons
Colonel Hack from the US Army Medical Research and Materiel Command will make a presentation focussed upon solving the problems evidenced in the 33+ Phase 111 clinical trials that have failed to show a positive outcome. Finally, the attendees may then be interested in the presentation by Larry Glass which will focus upon;
"a robust statistical methodology that offers the potential to manage Type I and II errors in a rigorous manner that enhances the ability to interpret Phase II results as well as assisting in the selection of clinically meaningful endpoints for pivotal/Phase III trials."
Last man standing with a plan for a successful Phase 111 trial.
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