Great discussion [Design Issues]

posted by ElMaestro  – Denmark, 2020-01-02 19:19 (1600 d 15:37 ago) – Posting: # 21055
Views: 7,266

Hello Ohlbe,

❝ 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.

A sore issue.
I think, and I cannot back this up with facts, that in some cases CROs are desperate to enroll subjects because they have signed a contract with all sorts of penalties for not initiating dosing on some specific date. I had several cases in 2019 of studies being postponed. The thing is, if one study gets postponed due to low enrollments, then it is not easy just to postpone the dosing a few days. You actually need serious rescheduling because you have several studies lined up. It is a nightmare and this is why a study where dosing is postponed due to slow enrollment is often not just postponed "a few days" but rather weeks.
I had several cases where I looked at the incidence of a PI or delegate NCS'ing subjects with low HB prior to studies. One case that stands out was one where the rate of NCS'ed subjects was extremely high -certainly higher than "normal" (as perceived by me)- on the last three days prior to dosing. This study included a HEVO male who had low:


I am trying to say that sometimes I think CROs are in need of subjects. I would not protest to anyone hinting that possibly a CRO here or there is putting pressure on PIs or delegates to enroll the enrollables.
Also, there are companies in Ahmedabad, Bangalore and Mumbai specialising in finding volunteers. Since there is no crosstalk between OVIS in Gujarat and similar software in e.g. Karnataka, you can rather safely take someone who is a recent participator from Gujarat to Bangalore without flags showing up.
This traffic of volunteers is big business. As in, really really big business.

As inspector or auditor I never had a chance to approach them. I have helped TV crews get inroads, but the people who are connected to these "humanitarian recruiters" are specifically people who do not like people like concepts like ethics, inspectors, auditors, and GCP. I have no doubt some of these people will happily break your leg and threaten to do stuff to members of your family in order to shut you up :-)
"Humanitarian recruiters" is a term I heard first during 2018. These people should apparently be awarded a Nobel Prize. They see themselves as career facilitators - poor people in remote areas who are in possession of valuable resources (think plasma and health) have a way to build a career and earn a living by signing up for trials (not to be confused with the ICF) via those people, who thereby help the local economy and so forth. Yes, these people are veritable saints, who get a cut like 50% of the volunteer compensation.
Some CROs are collaborating with these trafficking companies. I heard one guy saying they have no choice. In Ahmedabad the CRO industry has outgrown the volunteer pool. It is a rather precarious situation.

I heard of someone who was transported 450 km on top of a lorry from a remote area to CRO. If he was found enrollable but did not sign the ICF he would not be transported back to his village. He'd be stuck without a penny (rupee) in his pocket far away from home, and he did not know this condition before he departed. Now, try and see what GCP mentions about coercing someone to participate.
All this is of course completely off the radar for all formalised GCP activity and we can discuss wording of 4.8.3 and such but we will not be getting anywhere.

That is no way to treat humans. It royally pisses me off and I feel I can do absolutely nothing.

Bottom line: I am guessing that

Pass or fail!

Complete thread:

UA Flag
 Admin contact
23,034 posts in 4,835 threads, 1,647 registered users;
19 visitors (0 registered, 19 guests [including 6 identified bots]).
Forum time: 11:56 CEST (Europe/Vienna)

Give me a fruitful error any time, full of seeds, bursting with its own corrections.
You can keep your sterile truth for yourself.    Vilfredo Pareto

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