Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I wanted to know if a phase 2 study under IND can be unblinded prematurely? Would and amendment need to be submitted to FDA?

Thanks in advance!

With justification, any study can be unblinded prematurely. Such justifications should be very strong and not be taken lightly. Although  breaking the blind in a Phase 2 study may not have the same implications as that for a pivotal study, it still will impact the interpretation of the data. And, it partly depends on who sees the unblinded data and what subsequent actions are taken in the study. Whether an amendment is required also depends on why the blind is being broken. It is usually a complex enough question that a simple answer cannot be provided here.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 07-Sep-2021 15:28
From: Anonymous Member
Subject: Unblinding a Study Prematurely

This message was posted by a user wishing to remain anonymous

Hello,

I wanted to know if a phase 2 study under IND can be unblinded prematurely? Would and amendment need to be submitted to FDA?

Thanks in advance!

This message was posted by a user wishing to remain anonymous

For safety reasons lot of trials are unblinded prematurely!!! For a phase 2 study, yes you can unblind prematurely and make it an open study as long as you are not planning to use this trial as a registration trial later on .....................
Original Message:
Sent: 07-Sep-2021 15:28
From: Anonymous Member
Subject: Unblinding a Study Prematurely

This message was posted by a user wishing to remain anonymous

Hello,

I wanted to know if a phase 2 study under IND can be unblinded prematurely? Would and amendment need to be submitted to FDA?

Thanks in advance!