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wienui ★ Germany/Oman, 2020-01-05 19:22 (1795 d 05:53 ago) (edited on 2020-01-05 19:44) Posting: # 21057 Views: 6,556 |
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Dear colleagues, First of all, I wish you a happy successful new 2020. I face a situation for the first time, during evaluation of a BE study for a formulation which should be performed in fasting and fed conditions. both studies conducted in the same starting and ending period dates, till the moment I don't have something against that, but what makes me very worry is that both study were conducted in the same clinical site and both have the same principle investigator !!! Is there any GCP Guidelines which regulate ( allowed or prohibited) this issue? Best regards, Osama — Cheers, Osama |
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ElMaestro ★★★ Denmark, 2020-01-05 22:38 (1795 d 02:37 ago) @ wienui Posting: # 21058 Views: 4,372 |
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Dear wienui, ❝ First of all, I wish you a happy successful new 2020. Thanks and the same to you. ❝ I face a situation for the first time, during evaluation of a BE study for a formulation which should be performed in fasting and fed conditions. both studies conducted in the same starting and ending period dates, till the moment I don't have something against that, but what makes me very worry is that both study were conducted in the same clinical site and both have the same principle investigator !!! ❝ ❝ Is there any GCP Guidelines which regulate ( allowed or prohibited) this issue? Is this an issue at all? It is entirely common that the PI is one and the same for all studies at a given CRO or clinic, regardless of whether studies are conducted serially or concomitantly. At the end of the day the PI has overall responsibility and the delegation log (and training and ...) is the key to making sure the PI is not over-worked. In some countries the PI is purely an administrative matter; she or he will not see the subjects/patients but have everything delegated. These studies, including their formal setup, are OK to local authorities as well as to FDA, EMA/EU, TGA, PMDA, WHO, HC and more. — Pass or fail! ElMaestro |
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wienui ★ Germany/Oman, 2020-01-06 05:05 (1794 d 20:10 ago) @ ElMaestro Posting: # 21059 Views: 4,292 |
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Dear Cap't'n, ❝ Is this an issue at all? I think the risk of Mixing up is high when the PI and his/her clinical team are involved in both studies at the same time, think about adverse events which could be happened and his/her responsibility for the protection of study subjects, Mixing up in the collection of subjects study samples , ....etc ❝ In some countries the PI is purely an administrative matter; she or he will not see the subjects/patients but have everything delegated. I know that in some very rare cases that the PI has purely an administrative job, but mostely he/she is a physician who do practically the clinical part from A to Z. Best regards, Osama — Cheers, Osama |
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Ohlbe ★★★ France, 2020-01-06 13:27 (1794 d 11:48 ago) @ wienui Posting: # 21060 Views: 4,248 |
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Dear Osama, ❝ I think the risk of Mixing up is high when the PI and his/her clinical team are involved in both studies at the same time, think about adverse events which could be happened and his/her responsibility for the protection of study subjects, Mixing up in the collection of subjects study samples , ....etc Not to mention ethical concerns, with the fasting subjects smelling the breakfast eaten by the fed subjects  More seriously: it really depends on how the CRO is set up. Many CROs have several, clearly separated clinics within the same building, which can operate totally independently. No difference from trials being run separately in time. Having both trials being performed in the same room would indeed be at high risk, but not necessarily higher than having two trials on different drugs for different sponsors. ❝ ❝ In some countries the PI is purely an administrative matter; she or he will not see the subjects/patients but have everything delegated. ❝ ❝ I know that in some very rare cases that the PI has purely an administrative job, but mostly he/she is a physician who do practically the clinical part from A to Z. Again, in my experience it varies widely from one CRO to the next. Some CROs will appoint as principal investigator the most senior MD of the CRO, who will delegate most practical activities to sub-investigators. — Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2020-01-06 14:34 (1794 d 10:41 ago) @ Ohlbe Posting: # 21061 Views: 4,277 |
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Dear Ohlbe & all, first of all I agree with ElMaestro’s post. In my CRO the job of the PI was mainly administrative and he delegated the actual work to sub-investigators. ❝ Not to mention ethical concerns, with the fasting subjects smelling the breakfast eaten by the fed subjects Oh dear! Quoting one* of Kamal’s: The meal was prepared and served in a room on a different floor, well away from the room in which the fasting subjects were housed so that it was impossible for the latter to see or smell the food.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2020-01-28 21:16 (1772 d 03:59 ago) @ wienui Posting: # 21093 Views: 3,935 |
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Hi, ❝ but what makes me very worry is that both study were conducted in the same clinical site and both have the same principle investigator !!! Whats the issue? I did that before (PK studies done in Canada) J |
Ing. Helmut Schütz