I would avoid including information about “planned” clinical trials in the IB. Firstly, it’s not required. Secondly, plans frequently change potentially putting the sponsor in the situation of having to update the IB more frequently than the normal annual update. Just list the completed and ongoing trials making no commitments about potential future trials.
Mark De Rosch, PhD, FRAPS
Original Message:
Sent: 3/4/2024 11:34:00 AM
From: Anonymous Member
Subject: RE: Investigator Brochure and Planned Trials
This message was posted by a user wishing to remain anonymous
No harm in adding but it is unnecessary! Planned clinical trials section exists in Annual report for FDA! Your partner is probably a marketing oriented company!
Original Message:
Sent: 01-Mar-2024 16:03
From: Anonymous Member
Subject: Investigator Brochure and Planned Trials
This message was posted by a user wishing to remain anonymous
A company partner suggested that we add a brief section on planned clinical trials to our investigator brochure.
My initial thought is that such information goes beyond what is required for the IB and is not useful for its purpose, namely to inform investigators about the use of the product. I am not sure what the benefit would be to including such information in the IB, although I intend to follow up with our partner to understand why they would like to include it. Are there risks to adding that section? Are there alternatives we could consider for providing that information if our partner is adamant that we do so? I am aware that that information is captured in the IND annual report, etc.
I appreciate other perspectives. Thank you.