3+3 Design [Design Issues]

posted by Pharma_88 – India, 2020-01-07 09:09 (1129 d 01:22 ago) – Posting: # 21062
Views: 3,285

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

Complete thread:

UA Flag
Activity
 Admin contact
22,488 posts in 4,711 threads, 1,605 registered users;
20 visitors (1 registered, 19 guests [including 7 identified bots]).
Forum time: 10:32 CET (Europe/Vienna)

Many people tend to look at programming styles and languages like religions:
if you belong to one, you cannot belong to others.
But this analogy is another fallacy.    Niklaus Wirth

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5