In case Sdraw reads this board--repost from SA
Posted: Wed Mar 21, 2018 9:27 pm
Jay, I read every one of Sdraw's posts carefully and slowly. He has really helped me think about the data and structure of the various studies. I hope he reads this board because this question is for him (or anyone else who might be able to respond). I have always been sensitive to the ethics of how studies are structured and have sat on hospital IRBs that review studies. I just don't see how "closing P2 and moving quickly to P3" happens. I agree they want to close P2 but first off if they haven't reached median OS, the longer the wait the higher the impact but at some point as suggested by others after 24 months further OS determinations could take place after the study closes and the amendment allow for remaining patients to continue treatment and follow up. My issue is this. How does one structure a P3 in a terminal patient population? It implies a control arm. I think the ethics of this are apparent and hence the depth of foresight J and J had in hoping the FDA would allow a "historical control arm"--granted this is not pure. Sdraw, with all due respect (and you are due much) I don't see how they can do a P3 in R/R. Perhaps you were thinking a P3 for front-line? That would make good sense. If so please respond. Even if FDA allows a P3 for frontline we should see the drug approved for R/R patients (soon) and therefore on the market and maybe available for off label use earlier in the disease, (I have gotten some harsh responses for this suggestion) before but I still think it has validity and might make doing a front line study harder. Your points need no emphasis: 1. OS now in territory never before seen 2. Study closed early because a large sized group not required to prove statistical significance. That's a big one. Regards, bp
21 Mar 2018
21 Mar 2018