How many subjects should be enrolled in each arm in Phase I clinical trial?
Dr.Prajakt J.Barde CHP: “Enough” which translates to exactly what the protocol asked for. The number will be determined by the questions asked and the power of the given study in addition to a number of other variables. As a PI, I would always ask my friendly statistician if the number in the protocol is correct – and will not do the study as the protocol is written if she/he tells me the number is incorrect. Will ask Bala for a more scientifically correct answer.
