How to use 2nd passed pivotal study after 1st pivotal failed [Study Assessment]
Two pilot studies (2x2) passed for AUC and Cmax, a pivotal study (4x2) failed for both AUC and Cmax (AUC and Cmax ~130%, U95%CI ~1.40). Another large scale study passed. Would like to invalidate the failed pivotal study which had significant period effects (AUC and Cmax); a significant product*period*sequence effect; significant product differences were seen in periods 1 & 3, not in 2 & 4; within sequence product differences were significant within period 1 but not in sequence 2; CV ~ 35% for both AUC and Cmax in failed study; ~ 25% in past studies. I would like to use the second large study as pivotal. How can I do this - do I need to invalidate the pivotol study.
Edit: Category changed. Please follow the Forum’s Policy. [Helmut]
Edit: Category changed. Please follow the Forum’s Policy. [Helmut]
Complete thread:
- How to use 2nd passed pivotal study after 1st pivotal failedLouis 2015-11-24 21:35 [Study Assessment]
- How to use 2nd passed pivotal study after 1st pivotal failed ElMaestro 2015-11-24 23:08
- How to use 2nd passed pivotal study after 1st pivotal failed Mahmoud 2015-11-25 08:22
- 4-periods Helmut 2015-11-25 19:58
- More information, please Helmut 2015-11-25 19:53
- More information, please Louis 2015-11-27 17:02