Clinical Trial Disclosure Community

1.  Template for trial protocols to align with regs (NIH/EU 0070)?

Posted 17 days ago
Hello CT Disclosure Community - This grouping has amazing insights and so I'm looking to tap into your expertise and experience.
  • What are your thoughts on creating a P2-P4 protocol template to align with the various clinical transparency requirements? Is this standard practice today? Is it possible with all the various requirements?
  • What are the benefits to doing so (e.g., saves time, easier to publish) or is this a lower priority when faced with all the other activities to do?
  • What challenges might one consider to move template for greater transparency compliance?  
many thanks for your input
-Kim

------------------------------
Kimberly Belsky
Sr. Director, Regulatory Intelligence
Mallinckrodt Pharmaceuticals
------------------------------


2.  RE: Template for trial protocols to align with regs (NIH/EU 0070)?

Posted 15 days ago
Kim,
TransCelerate biopharma's common protocol template addresses the transparency concerns among other things and is in alignment with the FDA and NIH.​Common Protocol Template Assets - Clinical Trial Design
Transcelerate remove preview
Common Protocol Template Assets - Clinical Trial Design
The following resources have been made available to enable use of a streamlined model protocol template with common structure and language. The Common Protocol Template contains sections marked as common text or text that may be used across protocols with little to no editing if the user chooses to do so.
View this on Transcelerate >


------------------------------
Wendy Wimmer
Director, Regulatory Affairs
Merck & Co., Inc.
North Wales PA
------------------------------



3.  RE: Template for trial protocols to align with regs (NIH/EU 0070)?

Posted 12 days ago

Hi Kim,

 

That is a great question and I believe it is absolutely important to align protocol templates to reduce the amount of work towards the end when it is time to comply with these transparency regulations. It also helps in streamlining efforts on various regulations and minimize duplication of efforts as output could be bundled together to achieve maximum transparency and consistency across various public portals.

 

Thanks,

Rashmi

 

 

 






4.  RE: Template for trial protocols to align with regs (NIH/EU 0070)?

Posted 11 days ago
What would even drive more efficiency and compliance (and by the way, drive down costs) would sponsors to agree on core protocols per indication (and possibly class of IMP). Having "one" core protocol would make life for investigators, their teams, monitors and also reviewers in Health Authorities and Ethics Committees much more focused (and rapid). Agreeing on a protocol template only is nit even ¼ of the journey... Can groups like TransCelerate overcome "not invented here" attitudes?

------------------------------
Beat Widler
Co-Founder and Vice President, ACRES; Managing Director
Widler & Schiemann AG
Zug
+41(41)5589193
------------------------------



5.  RE: Template for trial protocols to align with regs (NIH/EU 0070)?

Posted 11 days ago
​Another benefit that we are anticipating is that the data for disclosure contained in a template will be circulated with the protocol/CSR and pre-reviewed for publication in a registry. Also, the people most familiar with the data are those who review the CSR and these are not always available for results review, and so, those most familiar with the project will have had the opportunity to review disclosure data while reviewing the CSR.

------------------------------
Joan Mariotti
Manager, Clinical Trial Disclosure
Teva Pharmaceutical
Malvern PA
+1(610)893-1056
------------------------------



6.  RE: Template for trial protocols to align with regs (NIH/EU 0070)?

Posted 11 days ago

​Dear all,

This topic has been and continues to be incorporated into TransCelerate's Common Protocol Template.

http://www.transceleratebiopharmainc.com/videos/transcelerate-common-protocol-template//

http://www.transceleratebiopharmainc.com/assets/common-protocol-template/

Jean Sposaro

Director Program Management
Regulatory Council Advisor
Sponsors Subcommittee
TransCelerate BioPharma Inc.




------------------------------
Jean Sposaro
TransCelerate BioPharma Inc.
Red Bank NJ
+1(908)268-8275
------------------------------



7.  RE: Template for trial protocols to align with regs (NIH/EU 0070)?

Posted 11 days ago

And also the core-reference has inputs on disclosure-readiness in the CSR template.

 

http://www.core-reference.org/media/1032/core-reference-v1_0.pdf

 

Thanks,

Rashmi

 






'