Human Research Ethics Committee and TGA Clinical Trials Discussion Forum, Communique, Meeting 1, 27 November 2024

The Therapeutics Goods Administration (TGA) hosted the first meeting of the Human Research Ethics Committee (HREC) and TGA Clinical Trials Discussion Forum (the Forum) on 27 November 2024. 

The Forum is an open group for HREC chairs or their delegates and aims to provide a mechanism for collaboration between the TGA and HRECs. It allows for informal discussions and information sharing on a range of emerging regulatory challenges and opportunities for clinical trials in Australia. The Forum is not an advisory or policy decision-making group and is not a statutory committee of the TGA. Terms of Reference (ToRs) for the Forum will be developed and distributed. 

The following topics were discussed: 

• Future discussion topics; including clinical trials using unapproved therapeutic goods, Authorised Prescriber and Special Access Scheme, communication and updates on TGA initiatives. 

Presentations were made on: 

• Review of the Clinical Trial Approval (CTA) scheme
  participants discussed: 
  • the optimal points in the CTA process for connection between HRECs and the TGA
  • whether HRECs are seeing trends in trials with high-risk investigational medicinal products (IMPs), particularly in vivo gene therapies 
  • whether HRECs are experiencing any challenges with evaluating these products
• Non-animal models. 

The next meeting is scheduled for April 2025.