wienui
★    

Germany, Oman,
2020-01-05 18:22
(edited by wienui on 2020-01-05 19:44)

Posting: # 21057
Views: 2,202
 

 The same PI for two studies in the same time [Study As­sess­ment]

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

Osama
ElMaestro
★★★

Belgium?,
2020-01-05 21:38

@ wienui
Posting: # 21058
Views: 691
 

 The same PI for two studies in the same time

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.

Le tits now.

Best regards,
ElMaestro
wienui
★    

Germany, Oman,
2020-01-06 04:05

@ ElMaestro
Posting: # 21059
Views: 664
 

 The same PI for two studies in the same time

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

Osama
Ohlbe
★★★

France,
2020-01-06 12:27

@ wienui
Posting: # 21060
Views: 646
 

 The same PI for two studies in the same time

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
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2020-01-06 13:34

@ Ohlbe
Posting: # 21061
Views: 638
 

 The same PI for two studies in the same time

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.



  • Midha KK, McKay G, Rawson MJ, Korchinski ED, Hubbard JW. Effects of Food on the Pharmacokinetics of Methlyphenidate. Pharm Res. 2001;18:1185–9. doi:10.1023/a:1010987212724.

Cheers,
Helmut Schütz
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jag009
★★★

NJ,
2020-01-28 20:16

@ wienui
Posting: # 21093
Views: 310
 

 The same PI for two studies in the same time

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
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