Bioequivalence and Bioavailability Forum

Dear neilfiona,

What I see quite often is that a few additional subjects (often called stand-by subjects) are indeed housed overnight. If one of the subjects assigned a number decides to pull out of the study before dosing in period 1, he will be replaced by one of the stand-by subjects, keeping the same subject number with a prefix (e.g. if subject 12 drops out, the replacement subject will be identified as R12 or 112). The replacement subject uses the same randomisation as the subject who dropped out (if 12 was RT, then R12 is also RT). This avoids having to generate an extra randomisation list, with the risk of unbalance.

Unused stand-by subjects leave the site once the last subject has been dosed and it is confirmed they are not needed. Standard practice is to give them a financial compensation for their time, and to give them priority to participate actively in the next study.