Hi Bear,
I am wondering with 6 Postive DSMB safety reviews , would the DSMB who have full viewing of the unblinded data if they saw the trial results of a RRR between 15 to 20% would they not have halted the trial for lack of efficacy or at least not hitting priamry endpoint of 30% RRR. Would it be ethical for the trial to contine the full 2 /12 years with the trial not meeting the expectations in their eys after 18 months or more, We are now close to 2 years and still going strong. If the DSMB had poor results in hand would they still want to see the trial go through 3 years to the end. Just curious as I am not a Clinician so i ahve absolutely no clue.....