Failed study [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-04-27 00:33 (476 d 13:45 ago) – Posting: # 22328
Views: 1,659

Hi mittyri,

» what is the proposed solution for such situation?
» say the subject did not swallow the IMP (just for fun) and investigators missed that.
» There's no way to prove this without direct subject's confession. Game over? The study failed?

Yep. To quote myself:

»[…] we cannot distinguish between lack of compliance (the subject didn’t take the drug), a product failure, and a subject-by-formulation interaction (the subject belongs to a subpopulation).«


Dif-tor heh smusma 🖖 [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).
Forum time: Tuesday 14:19 CEST (Europe/Vienna)

In matters of style, swim with the current;
in matters of principle, stand like a rock.    Thomas Jefferson

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