I didn't participated in the recent meeting but if
Post# of 72445
(Total Views: 638)
Posted On: 09/21/2019 12:17:24 PM
I didn't participated in the recent meeting but if I gather corectly all pertinent info from all my friendly long term investors, B-OM clinical trial (CT) will look like this:
1. Randomized
2.Blinded
3.placebo controlled
4. 2 :1 randomization ( 75% chance that patient will be blindly randomized to B arm of the trial )
5. Accrual target : 450 patients
6. Possibilities hoping for : cross-over design ,midterm analysis , QoL data as an end point of the trial
My comment is that FDA accepting this trial protocol would like to support well powered trial ,giving quickly answers to the efficacy questions ( efficacy end points) in the statistically meaningful fashion .
With 2-4 ( I am sure its going to be 10-20 likely) cancer centres participating it shouldn't be very long to know all the answers and if this trial has mid term analysis we can have the study completed within 3-6 month if not sooner.Mid size cancer centre sees 100 cases of H&N cancer per year so the pace of this trial is easy to imagine
My opinion only
aragon
1. Randomized
2.Blinded
3.placebo controlled
4. 2 :1 randomization ( 75% chance that patient will be blindly randomized to B arm of the trial )
5. Accrual target : 450 patients
6. Possibilities hoping for : cross-over design ,midterm analysis , QoL data as an end point of the trial
My comment is that FDA accepting this trial protocol would like to support well powered trial ,giving quickly answers to the efficacy questions ( efficacy end points) in the statistically meaningful fashion .
With 2-4 ( I am sure its going to be 10-20 likely) cancer centres participating it shouldn't be very long to know all the answers and if this trial has mid term analysis we can have the study completed within 3-6 month if not sooner.Mid size cancer centre sees 100 cases of H&N cancer per year so the pace of this trial is easy to imagine
My opinion only
aragon
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