Hi anonymous,
This particular scenario seems to fall squarely within the FDA's description of changes requiring a protocol amendment (from their website on this topic):
"...changes requiring an amendment to an IND application may include:
While it may be tempting to dispute the threshold for what size of increase constitutes a 'significant increase', it is generally safer to submit an amendment rather than capture this an annual report. That being said, if there is a clear provision in the original protocol for increasing the sample size (for instance, an interim analysis or dropout/replacement strategy), this may not require an amendment.
Cheers,
Marshall Hoke
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Marshall Hoke
Director of Regulatory Affairs
Lafayette CO
United States
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Original Message:
Sent: 24-Jun-2021 13:18
From: Anonymous Member
Subject: IND Protocol Change - Submission type
This message was posted by a user wishing to remain anonymous
Hi Everyone,
I was looking to get a bit more clarification regarding a scenario. If you increase the number of subjects in a Phase II study, does this need to be submitted as a protocol amendment or can it be captured in the annual IND report?
Thanks for your help!