Bioequivalence and Bioavailability Forum

Hi Norah,

❝ […] a BE study where I planned to perform a drug (cannabis, THC, ... ) screening to volunteers before confinement. The Ethic committee rejected this because local laws require the person who discovers a consumer to declare him for imprisonment.

Interesting. Since the job of the ethics committee is to protect volunteers from risks, this makes sense. The WHO’s guideline states:

3.2 Ethics committee
When reviewing a clinical trial proposal the ethics committee should consider the following:
b) The suitability of the protocol including the objectives of the study and the justification of predictable risks and inconveniences weighed against the anticipated benefits for the subjects and/or others …
3.3 Informed consent
b) The subject must be made aware and consent that personal information may be scrutinized during monitoring, auditing or inspection of the trial by properly authorized persons, the sponsor or relevant authorities, and that participation and personal information in the trial will be treated as confidential and will not be publicly available. This principle may be modified by national laws and regulations.

Getting imprisoned is inconvenient at least.

❝ Is the drug screening mandatory??

Not mandatory but I never ever have seen a BE study without one.

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,

Relaxation.

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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]

❝ Is the drug screening mandatory??

In Mexico for BE you have to perform abuse test by law
"8.7.14 Qualitative evidence of drug abuse and pregnancy must be performed during the selection process and prior to admission in each study period" NOM-177-SSA1-2013.

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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 #5! Document linked. [Helmut]