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Posted On: 04/25/2019 11:30:24 AM
Post# of 72446
excellent comments Pete.
If I may add, I think this is going to be double blinded, randomize , placebo controlled , multinational, multicenter , crossover design , well powered trial .Crossover design will give investigators the power to unblind the patient and if on placebo move into B-OM arm of the study.
Mid trial interim analysis would be an essence and must be in the study protocol suggested by FDA,EMA and in the best unrest of IPIX
With the present H/N cancer epidemiology worldwide it should be quick 6-12 month trial if not quicker .Accrual would be speedy !!!!
My opinion only
aragon
If I may add, I think this is going to be double blinded, randomize , placebo controlled , multinational, multicenter , crossover design , well powered trial .Crossover design will give investigators the power to unblind the patient and if on placebo move into B-OM arm of the study.
Mid trial interim analysis would be an essence and must be in the study protocol suggested by FDA,EMA and in the best unrest of IPIX
With the present H/N cancer epidemiology worldwide it should be quick 6-12 month trial if not quicker .Accrual would be speedy !!!!
My opinion only
aragon
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