Author Topic: AE vs Relation to Drug  (Read 2582 times)

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Offline VM QA

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AE vs Relation to Drug
« on: Tue, 20 Apr 2010 »
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Hi All!

I had a query regarding AE vs. Relation to drug?

Ex: X is having AE (Giddiness) which was relation to study drug is 'Unlikely'
      Y  is having AE (Giddiness) which was relation to study drug is 'Possible'

In the above cited ex. the formulation administered is same for X & Y.
However, in protocol side effects section giddiness was not mentioned.

Kindly suggest me !

VM

Offline Clin_DM

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Re: AE vs Relation to Drug
« Reply #1 on: Wed, 21 Apr 2010 »
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Hi All!

I had a query regarding AE vs. Relation to drug?

Ex: X is having AE (Giddiness) which was relation to study drug is 'Unlikely'
      Y  is having AE (Giddiness) which was relation to study drug is 'Possible'

In the above cited ex. the formulation administered is same for X & Y.
However, same side effect (Giddiness) may occur due to admin of IP was not captured in the protocol.

Kindly suggest me !

VM

Hi,

I didn't understand the last line of your post - "same side effect (Giddiness) may occur due to admin of IP was not captured in the protocol"

While deciding the AE's relationship to study drug, many factors are taken in the consideration like start time, duration, time of IMP administration etc.

It is up to the investigator to clinically correlate everything and to decide whether the relationship to study drug for that AE is Unlikely or Possible.

Regards,
Clin_DM

Offline madhurimurahari

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Re: AE vs Relation to Drug
« Reply #2 on: Thu, 22 Apr 2010 »
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 :) Hi Friend,

Relatio to the drug can be called as "Causality Assessment". Causality assessment is the method by which the extent of relationship between a drug and a suspected reaction is established

Causality can be derived by some points in consideration, they are:

According to WHO Scale:  CERTAIN, PROBABLE/ LIKELY , POSSIBLE, UNLIKELY, CONDITIONAL/ UNCLASSIFIED, UNASSESSIBLE/ UNCLASSIFIABLE.
Each one as some criteria to be fulfilled.

Coming to your Eg, Possible can be A clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug, but which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear.

So, Subject may have giddiness which can also be due to the concurrent disease or con medication.
Since it is not exactly due to the IP, it may be not mentioned in the protocol as known AE. But it can be considered as a SIGNAL and can be investigated further.

Hope I made it clear,
Regards
Madhuri

Offline Clin_DM

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Re: AE vs Relation to Drug
« Reply #3 on: Thu, 22 Apr 2010 »
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:) Hi Friend,

Relatio to the drug can be called as "Causality Assessment". Causality assessment is the method by which the extent of relationship between a drug and a suspected reaction is established

Causality can be derived by some points in consideration, they are:

According to WHO Scale:  CERTAIN, PROBABLE/ LIKELY , POSSIBLE, UNLIKELY, CONDITIONAL/ UNCLASSIFIED, UNASSESSIBLE/ UNCLASSIFIABLE.
Each one as some criteria to be fulfilled.

Coming to your Eg, Possible can be A clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug, but which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear.

So, Subject may have giddiness which can also be due to the concurrent disease or con medication.
Since it is not exactly due to the IP, it may be not mentioned in the protocol as known AE. But it can be considered as a SIGNAL and can be investigated further.

Hope I made it clear,
Regards
Madhuri

Hi Madhuri,

Thanks for the nice explanation!

I have one question here. Relationship to study drug is always a PI's call! So as an auditor or CDM person, can I challenge PI's decision of putting relationship to study drug for one AE as 'Possible' for one patient and for the same AE, under the similar circumstances, 'Probable' for the other one?

Waiting for your valuable inputs.

Regards,
Clin_DM

Offline madhurimurahari

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Re: AE vs Relation to Drug
« Reply #4 on: Thu, 22 Apr 2010 »
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 :) Hi Clin_DM,

If that is the case, detailed study of that case and the AE is done by the investigation team / Drug Safety team of the sponsor along with the investigator for a clear output.

As a CDM member u can raise a query to the PI.

Regards
Madhuri

Offline Clin_DM

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Re: AE vs Relation to Drug
« Reply #5 on: Fri, 23 Apr 2010 »
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Hi Madhuri,

Investigator, in that case, says that he has to decide that based on the clinical judgments and CDM guy, being a non-medico can't question an investigator on this!

Please give your valuable inputs on this.

Regards,
Clin_DM

Offline madhurimurahari

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Re: AE vs Relation to Drug
« Reply #6 on: Fri, 23 Apr 2010 »
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 :) Dear Clin_DM,

You cannot cross question or argue with a investigator but there is no markation that u shoud not ask doubt. if u find these cases while entering in to the CRF u can ask them for judgement (Soothing way). Because as far as I know CDM people can raise queries to investigator regarding Codin and all. Actually Drug Safety team member would be the right person to approach in such cases.

Correct me if I am Wrong
Regards
Madhuri

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