The Therapeutic Goods Administration has advised of a major update and re-structure of the Australian clinical trials handbook.
The updated Australian clinical trial handbook provides policy guidance on the clinical trials schemes administered by the TGA. Guidance on the notification process for the Clinical Trial Notification (CTN) scheme is available at Clinical trial notification form – user guide.
The latest handbook update provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using ‘unapproved’ therapeutic goods.
It assists trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) to understand their roles and responsibilities under the therapeutic goods legislation.
The TGA said clinical trials involving therapeutic goods are generally undertaken to assess the effects, efficacy, performance and/or safety of the product. It is therefore necessary that clinical trials are conducted using appropriate experimental designs to obtain valid data without exposing participants to unnecessary risks. Before starting a clinical trial, all parties should be satisfied that the rights, safety and well-being of trial participants will be protected and that clinical trial data generated will be reliable and robust.
The TGA said the handbook does not describe all of the requirements for conducting clinical trials in Australia. It refers to other relevant publications throughout that should be read in conjunction with this guidance. This handbook describes the two schemes under which clinical trials involving ‘unapproved’ therapeutic goods may be conducted in Australia: · Clinical Trial Notification (CTN) scheme · Clinical Trial Exemption (CTX) scheme Clinical trials that do not involve the use of ‘unapproved’ therapeutic goods are not subject to the requirements of the CTN and CTX schemes.
The Handbook has been updated to reflect current practice. They have also consolidated information from the following previous clinical trials guidance documents:
- Access to unapproved therapeutic goods – Clinical trials in Australia;
- Australian Clinical Trial Handbook; and,
- Human Research Ethics Committees and the therapeutic goods legislation
The TGA website also describes the two schemes under which clinical trials involving ‘unapproved’ therapeutic goods may be conducted in Australia:
Clinical trials that do not involve the use of 'unapproved' therapeutic goods are not subject to the requirements of the CTN and CTX schemes. The TGA said guidance on the application process for the Clinical Trial Exemption (CTX) scheme is currently under review.