IRB reserves [Design Issues]

posted by Relaxation  – Germany, 2018-01-16 19:18 (1968 d 20:17 ago) – Posting: # 18186
Views: 6,492

Hello to all.

To add my 2 cents.
As far as I know (better "remember", my training on the protocol template was admittedly not recent), there is only one relevant reason for drug screening: to have a test for subjects with an increased risk of non-compliance to study conditions. It's not fair to assume that all drug users are unreliable (and for me a little bit inadequate), but it is a point.
In addition, it might be that subjects will misbehave during the stay at the clinical side if drugged, so there is another point.

I personally agree with the approach to exclude subjects that may consume drugs as I would consider this as a specific kind of concomitant medication. Maybe there could be a PK interaction, maybe not, but you would have to implement additional checks or at least a discussion on any analytical interference at your bioanalytical department in any case.

Still, all these are issues that are basically organisational problems of the sponsor, can be handled in other ways and may not make a drug test mandatory.

On the other hand, I also have no example of a clinical trial, where such tests were not part of the protocol.
But they also were always explicitly mentioned in the subject information I know of (OK, subjects do not read them - we had several cases ourself, if only people smoking right in front of the entrance and then complaining on the test for cotinine ;-) we enforced "in case of suspicion").

I am not sure how the IEC would react to this argument, but actually, if the subjects are informed and still show up for the test ... its not really your fault, is it?

Best regards,


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

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