(Total Views: 611)
Posted On: 05/30/2025 12:10:09 AM
Post# of 153778
Quote:
Primary completion date 06/28
Study completion date 08/28...ALL ESTIMATED...
IF the results are righteous ...is there a mid-point for examination of interim results.?
Actual end date of the trial is 12 months after the last patient is enrolled. The data safety monitoring board will look at the first 5 patients in the 350mg arm for safety before the 700mg arm starts. At some point they will also look at upgrading the 350mg patients to 700mg. Usually around halfway through a trial they'll compile all the current data looking at safety and efficacy and recommending trial continuance, ending the trial due to futility or changes to the trial. That data is generally known only to the DMSB because if the sponsor of the trial or CRO knows the data it could influence the trial. However with very promising data the company will sometimes request its release to them.
(12)
(0)
