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.