Great discussion [Design Issues]

posted by Ohlbe – France, 2020-01-02 15:57  – Posting: # 21053
Views: 605

Dear ElMaestro,

» Can you guys think of any other biomarker/indicator unrelated to blood loss or the regenerative process?

Needle prick marks in the forearm veins, if the subject is so greedy (or hungry :-() that he does not even wait for them to heal ? Well, actually it would be relevant, if I am to believe Zeba Ziddiqui's paper which you mentioned earlier (with subjects participating in 3 or 4 trials in the same month). I never saw a protocol with a non-inclusion criterion "Subject with needle marks in the forearm". So I never saw a tick box anywhere in the screening documentation with this criterion.

I'm not aware of any other indicator, unfortunately.

By the way, I really don't see how a subject could participate in 3 or 4 trials in the same month without the CRO(s) being aware of it. I'm really not sure whether some of the CROs are really willing to know whether the subjects cross-participate.

[image] © Roberto Mangosi

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
20,250 posts in 4,262 threads, 1,398 registered users;
online 19 (0 registered, 19 guests [including 10 identified bots]).
Forum time (Europe/Vienna): 05:52 UTC

No written law has ever been more binding than
unwritten custom supported by popular opinion.    Carrie Chapman Catt

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