Unless explicitly stated by the company that they started the Phase I portion and then later stated they started the Phase II portion, a Phase I/II trial will START in the more advanced phase. This is will slightly bias the data to have less earlier stage successes, as there would not be a 'Phase I' transition or success in that instance. In many ways, the company has pushed the risk forward to Phase II by running a joint Phase trial.
How do you handle multi-Phase studies or programs (i.e. Phase I/II etc.)?
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Written by Shubh Dasgupta