Clinical Trials in Australia
Overview
Clinical trials of unapproved medical devices in Australia are regulated under the Therapeutic Goods Act 1989. Devices used in clinical trials must be covered by either the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme. Most medical device clinical trials in Australia are conducted under the CTN scheme, which is administered by Human Research Ethics Committees (HRECs) rather than the TGA. The TGA retains oversight of clinical trials and can intervene where safety concerns arise.
Clinical Trial Notification (CTN) Scheme
The CTN scheme is the most common pathway for medical device clinical trials in Australia. Under CTN:
- The trial is approved by a Human Research Ethics Committee (HREC) — the HREC, not the TGA, is the primary oversight body
- The trial sponsor notifies the TGA of the trial (a notification, not an application for approval)
- The TGA does not assess the trial protocol or review trial documentation before the trial commences
- The TGA retains the power to intervene if safety concerns arise
This places significant responsibility on the HREC to review the safety and scientific merit of the trial.
Clinical Trial Approval (CTA) Scheme
Under CTA, the TGA assesses the safety and scientific data before approving the trial. This is a more burdensome pathway used for:
- Trials where HREC is not satisfied with available safety data
- Trials referred to TGA for specific reasons
- Biologicals (more commonly)
Most medical device trials use CTN rather than CTA.
Exemption from ARTG Requirements
Unapproved devices used in clinical trials are exempt from the requirement to be included in the ARTG, provided the trial is conducted under CTN or CTA and meets the applicable conditions. The exemption is conditional — it does not apply if the device is being supplied for purposes beyond the clinical trial.
Good Clinical Practice (GCP)
Clinical trials of medical devices must be conducted in accordance with Good Clinical Practice (GCP) requirements. The TGA may conduct GCP inspections of trial sites. GCP requirements for medical device trials in Australia align with the ISO 14155 standard on clinical investigation of medical devices for human subjects.
Relevant standard: ISO 14155 — Clinical investigation of medical devices for human subjects
Key Obligations for Trial Sponsors
- Notify the TGA via the CTN scheme before commencing the trial
- Ensure HREC approval is obtained and maintained
- Maintain insurance and indemnification arrangements
- Report serious adverse events from the trial to the TGA and HREC
- Conduct the trial in accordance with GCP and the approved protocol
- Report trial results as required