3+3 Design [Design Issues]

posted by Pharma_88 – India, 2020-01-07 08:09 (651 d 01:59 ago) – Posting: # 21062
Views: 2,879

Hello All,

This is regarding 3+3 design for Phase-I trial. I have searched online and found some articles on design. My Question is that once the group/cohort is completed with 3 patients, whether same patients will be enrolled in next cohort or new patient will be enrolled? Further, in next cohort suppose 1 patient is withdarwn or have some AE then its compulsory to add 3 more patients to inline with multiplication of 3?

Thanks,
Pharma_88

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