‘Add-on’ design? [Study Performance]
❝ I don’t understand. The study is completed and the sponsor wants to increase the sample size – because the study failed?
Study is completed and wants to do additional study with some additional subjects and planning to retrieve IPs from previous passed study. For test they are using old IPs and reference they are getting new IPs of same batch for the conduct of study. Our doubt is whether we have to have retention quantity for both old study and new study.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]