Clinical Trials Regulatory Framework

Clinical Trials Regulatory Framework

TGA has published the Australian clinical trials handbook, a guidance on conducting clinical trials in Australia using unapproved therapeutic goods. The handbook includes tables that summarize the clinical trial phases for medicines and biologicals: Phase 0, I, II, III and IV; and the clinical trials stages for medical devices: pre-market pilot, pre-market pivotal and post-market.   

Pre-market pilot studies are exploratory investigations to determine preliminary safety and performance information to plan design modifications or provide support for a future pivotal study; they include:

  • Early feasibility studies are limited clinical investigations during early device development, typically before the device design has been finalized. 

  • First-in-human (FIH) studies are a type of study in which a device for a specific indication is evaluated for the first time in human subjects. 

  • Traditional feasibility studies are clinical investigations used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan an appropriate pivotal study. A traditional feasibility study does not necessarily need to be preceded by an early feasibility study.

Pre-market pivotal studies are confirmatory investigations to evaluate performance and safety for a specified intended use to satisfy pre-market regulatory requirements. 

Post-market studies are confirmatory investigations to establish performance and safety, for example, in broader populations; or observational investigations or surveillance to gain better understanding of device safety, long-term outcomes, health economics. 

The Australian clinical trials 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 Approval (CTA) scheme 

Clinical trials that do not involve the use of 'unapproved' therapeutic goods are not subject to the requirements of the CTN and CTA schemes.