Great discussion [Design Issues]

posted by Ohlbe – France, 2020-01-02 15:57 (496 d 11:29 ago) – Posting: # 21053
Views: 4,382

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


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