Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

First, I would just like to say that this forum is extremely helpful!  All of the advice is greatly appreciated.

Unfortunately, the regulations for the IB are very vague.  My question pertains to reporting AEs from completed clinical studies -  should all of the AEs be identified, even if they were classified as not drug related?

Thank you so much for your guidance.

This is one of those areas where there is not a rule to follow.  The IB should include any available safety information that would allow an investigator giving the product to a subject to do so as safely as possible.  So the question you have to answer is whether the unrelated AEs provide clinically useful information in this context. A medical monitor or someone else with clinical expertise might be helpful here. One consideration is that AE attribution is simply the reporting investigator's or sponsor's opinion rather than a factual data point. Other considerations are the stage of clinical development (how much is known about clinical safety so far), novelty of the product (first in call or something with relevant clinical precedent, and the seriousness of the disease or adverse events.  Taken together, these can help you judge what is best in your situation.

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Kathryn Wekselman
Senior Director, Regulatory and Scientific Affairs
CTI Clinical Trial and Consulting Services
Cincinnati OH
United States
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Original Message:
Sent: 09-Jan-2018 13:50
From: Anonymous Member
Subject: Investigator's Brochure (IB) and AEs

This message was posted by a user wishing to remain anonymous

First, I would just like to say that this forum is extremely helpful!  All of the advice is greatly appreciated.

Unfortunately, the regulations for the IB are very vague.  My question pertains to reporting AEs from completed clinical studies -  should all of the AEs be identified, even if they were classified as not drug related?

Thank you so much for your guidance.

Regulatory agencies are increasingly only interested in only related events for reporting purposes.  For example, SUSARs are not to be reported if they occurred on blinded placebo or comparator.  For labeling purposes, FDA prefers to include only ADRs as determined by frequency compared to placebo.  I agree with Kathryn's advice to include in the discussion the company safety experts in what events to include based on what the investigator needs to know and not include irrelevant events that obfuscate the real events to be concerned about.

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Glen Park
Scynexis, Inc.
Jersey City NJ
United States
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Original Message:
Sent: 09-Jan-2018 13:50
From: Anonymous Member
Subject: Investigator's Brochure (IB) and AEs

This message was posted by a user wishing to remain anonymous

First, I would just like to say that this forum is extremely helpful!  All of the advice is greatly appreciated.

Unfortunately, the regulations for the IB are very vague.  My question pertains to reporting AEs from completed clinical studies -  should all of the AEs be identified, even if they were classified as not drug related?

Thank you so much for your guidance.