Dose escalation and DMC [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-01-07 12:18 (382 d 18:33 ago) – Posting: # 21064
Views: 1,777

Hi Pharma_88,

I agree with what Ohlbe wrote.

Note that the decision on whether or not to proceed to the next cohort must not be done at the clincal site but by an external Data Monitoring Committee (DMC). See also the EMA’s Guideline.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,310 posts in 4,445 threads, 1,489 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Sunday 06:52 CET (Europe/Vienna)

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

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