Regulatory Open Forum

Hi all,

Planning for first IND annual report for a clinical trial (cross-referencing manufacturer's IND, marketed product) which involves both US sites and OUS sites.  We are partnered with another organization running the OUS portion of the trial, while US sites are under our IND.  Most of my IND's are US-only, so here's my question regarding safety data from the OUS sites:

- Would you normally include all of them in combined tables?
- or separate them out (report US sites and OUS sites in separate columns)
- or report only the US site data, since the OUS sites are separate and reported under a separate filing in that country?

Thanks!  Ken

------------------------------
Kenneth Rockwell
Director of Regulatory Affairs
Philadelphia PA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

All safety data must be reported to the US IND from worldwide! 

"- or report only the US site data, since the OUS sites are separate and reported under a separate filing in that country?" Absolutely NO
Original Message:
Sent: 20-Jul-2021 11:51
From: Kenneth Rockwell
Subject: IND annual report - US vs OUS safety data

Hi all,

Planning for first IND annual report for a clinical trial (cross-referencing manufacturer's IND, marketed product) which involves both US sites and OUS sites.  We are partnered with another organization running the OUS portion of the trial, while US sites are under our IND.  Most of my IND's are US-only, so here's my question regarding safety data from the OUS sites:

- Would you normally include all of them in combined tables?
- or separate them out (report US sites and OUS sites in separate columns)
- or report only the US site data, since the OUS sites are separate and reported under a separate filing in that country?

Thanks!  Ken

------------------------------
Kenneth Rockwell
Director of Regulatory Affairs
Philadelphia PA
United States
------------------------------

You have described a complicated relationship between your IND and the manufacturer's IND and your OUS partner. It is not clear from what you say whether the manufacturer's IND is active and what is your agreement with them allowing you to cross-reference their IND. That agreement should spell out safety reporting for their drug. Regardless, all safety data for the molecule needs to be reported to FDA, whether collected in the US or not.

I would recommend reporting separately the US and OUS safety data since event rates can often be different.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 20-Jul-2021 11:51
From: Kenneth Rockwell
Subject: IND annual report - US vs OUS safety data

Hi all,

Planning for first IND annual report for a clinical trial (cross-referencing manufacturer's IND, marketed product) which involves both US sites and OUS sites.  We are partnered with another organization running the OUS portion of the trial, while US sites are under our IND.  Most of my IND's are US-only, so here's my question regarding safety data from the OUS sites:

- Would you normally include all of them in combined tables?
- or separate them out (report US sites and OUS sites in separate columns)
- or report only the US site data, since the OUS sites are separate and reported under a separate filing in that country?

Thanks!  Ken

------------------------------
Kenneth Rockwell
Director of Regulatory Affairs
Philadelphia PA
United States
------------------------------

Hi Glen,

Thank you!  We operate as a nonprofit, we don't manufacture anything but we partner with both pharma and academia.  Our trials  typically originate in academia but are far too large or complex for a single institution to carry out.  In this case we have one large trial split in two, with a pharma partner providing agent and financial support, our organization handling all US sites and a partner organization (another nonprofit) handling OUS sites (Australia/NZ) under a separate TGA filing.  All sites worldwide are using a central data collection - so we have the ability to report out combined or separately.

What I've wondered about is whether it makes sense to separate out the safety data (US and OUS) such as in separate columns, or combine them all into one, or perhaps both.

Thanks!  Ken

------------------------------
Kenneth Rockwell
Director of Regulatory Affairs
Philadelphia PA
United States
------------------------------

Original Message:
Sent: 22-Jul-2021 08:02
From: Glen Park
Subject: IND annual report - US vs OUS safety data

You have described a complicated relationship between your IND and the manufacturer's IND and your OUS partner. It is not clear from what you say whether the manufacturer's IND is active and what is your agreement with them allowing you to cross-reference their IND. That agreement should spell out safety reporting for their drug. Regardless, all safety data for the molecule needs to be reported to FDA, whether collected in the US or not.

I would recommend reporting separately the US and OUS safety data since event rates can often be different.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 20-Jul-2021 11:51
From: Kenneth Rockwell
Subject: IND annual report - US vs OUS safety data

Hi all,

Planning for first IND annual report for a clinical trial (cross-referencing manufacturer's IND, marketed product) which involves both US sites and OUS sites.  We are partnered with another organization running the OUS portion of the trial, while US sites are under our IND.  Most of my IND's are US-only, so here's my question regarding safety data from the OUS sites:

- Would you normally include all of them in combined tables?
- or separate them out (report US sites and OUS sites in separate columns)
- or report only the US site data, since the OUS sites are separate and reported under a separate filing in that country?

Thanks!  Ken

------------------------------
Kenneth Rockwell
Director of Regulatory Affairs
Philadelphia PA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Safety information is about your molecular entity in a particular dosage form/strength/indication so separating from US versus OUS is not going to be anything value added! Just so you are aware there is no requirement to separate it out!
Original Message:
Sent: 22-Jul-2021 11:06
From: Kenneth Rockwell
Subject: IND annual report - US vs OUS safety data

Hi Glen,

Thank you!  We operate as a nonprofit, we don't manufacture anything but we partner with both pharma and academia.  Our trials  typically originate in academia but are far too large or complex for a single institution to carry out.  In this case we have one large trial split in two, with a pharma partner providing agent and financial support, our organization handling all US sites and a partner organization (another nonprofit) handling OUS sites (Australia/NZ) under a separate TGA filing.  All sites worldwide are using a central data collection - so we have the ability to report out combined or separately.

What I've wondered about is whether it makes sense to separate out the safety data (US and OUS) such as in separate columns, or combine them all into one, or perhaps both.

Thanks!  Ken

------------------------------
Kenneth Rockwell
Director of Regulatory Affairs
Philadelphia PA
United States

Original Message:
Sent: 22-Jul-2021 08:02
From: Glen Park
Subject: IND annual report - US vs OUS safety data

You have described a complicated relationship between your IND and the manufacturer's IND and your OUS partner. It is not clear from what you say whether the manufacturer's IND is active and what is your agreement with them allowing you to cross-reference their IND. That agreement should spell out safety reporting for their drug. Regardless, all safety data for the molecule needs to be reported to FDA, whether collected in the US or not.

I would recommend reporting separately the US and OUS safety data since event rates can often be different.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 20-Jul-2021 11:51
From: Kenneth Rockwell
Subject: IND annual report - US vs OUS safety data

Hi all,

Planning for first IND annual report for a clinical trial (cross-referencing manufacturer's IND, marketed product) which involves both US sites and OUS sites.  We are partnered with another organization running the OUS portion of the trial, while US sites are under our IND.  Most of my IND's are US-only, so here's my question regarding safety data from the OUS sites:

- Would you normally include all of them in combined tables?
- or separate them out (report US sites and OUS sites in separate columns)
- or report only the US site data, since the OUS sites are separate and reported under a separate filing in that country?

Thanks!  Ken

------------------------------
Kenneth Rockwell
Director of Regulatory Affairs
Philadelphia PA
United States
------------------------------