Hb level [Design Issues]

posted by ElMaestro  – Belgium?, 2019-12-31 15:19 (303 d 13:45 ago) – Posting: # 21040
Views: 3,797

Hi Ohlbe,

» It is fairly common for healthy volunteers in India to have a Hb level below 13 g/dl (I'd even say that based on ElMaestro's definition of "5% of normal folks are outside of the normal range", the normal range used by many labs in India does not seem to have been adapted to the population they usually serve). You can live a perfectly normal life with a Hb level between 12.5 and 13 g/dl. Where I become somewhat uneasy is that you are going to collect a few hundred ml of blood from these subjects. And that ethically and in the subject's best interest, you should avoid doing this from subjects who already have a borderline low Hb level. In France, you can only do a blood donation if your Hb level is at least 14 g/dl. I don't know whether there is an official limit in India.

Without pointing fingers anywhere, I'd say you'll be really lucky to have just 1 out of 50 with that hemoglobin level in certain regions from which many, many EU-approved BE dossiers originate.
We should also bear in mind that dietary habits and life style can play a role for HB. But there are very few answers on it.

» Another aspect, again specifically for Hb: this can also be an indication of over-participation in BE trials / CRO shopping. I do not trust 100% the databases (OVIS and the like) which have been put in place against this.

Zeba Ziddiqui from Reuters touched upon this topic in a little piece from 2016.

I could be wrong, but...

Best regards,

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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