3+3 Design [Design Issues]

posted by Pharma_88 – India, 2020-01-07 09:09 (1505 d 17:43 ago) – Posting: # 21062
Views: 3,567

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
22,899 posts in 4,806 threads, 1,651 registered users;
20 visitors (0 registered, 20 guests [including 7 identified bots]).
Forum time: 02:53 CET (Europe/Vienna)

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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