Document ID: chunk:federal_register_of_legislation:F2022C00752:reg:4:p2
Version: federal_register_of_legislation:F2022C00752
Segment Type: reg
Provision Reference: reg 4 (pt 2/2)
Character Range: 5483–8108

trial to determine optimum therapeutic dose and regimen (with efficacy as the primary endpoint); and to resolve uncertainties regarding the design and conduct of subsequent trials.
phase III clinical trial (therapeutic confirmatory) means a clinical trial that involves a large group of patients and aims to evaluate the safety, efficacy or effectiveness of a medicine or biological. Trials may be phase IIIa or phase IIIb as follows:
 (a) Phase IIIa: a clinical trial to determine the therapeutic effect in patient populations for which the drug is eventually intended. It provides a definitive assessment of risk-benefit balance (to support drug registration or change in clinical practice);
 (b) Phase IIIb: a clinical trial to increase patient exposure and support marketing claims or publication.
phase IV clinical trial (therapeutic use) means a clinical trial of a medicine or biological that includes the following:
 (a) post-marketing surveillance or resolution of treatment uncertainties;
 (b) monitoring safety in real-world populations;
 (c) refining knowledge of the risk-benefit balance, detecting rare or long-term adverse effects, and drug interactions;
 (d) pharmacoeconomics to gather data in support of the use;
 (e) comparative effectiveness and community-based research (sometimes described as phase V trials);
 (f) trial combinations with existing products.
post-market stage clinical trial means a confirmatory investigation of a medical device to establish performance and safety; or observational investigations or surveillance to gain a better understanding of device safety, long-term outcomes, and health economics.
pre-market pilot stage clinical trial means a clinical trial of a medical device that involves a small group of human patients with the objective of being an exploratory investigation to determine preliminary safety and performance information to plan design modifications or provide support for a future pivotal study. It includes first in human and feasibility studies or proof of concept.
pre-market pivotal stage clinical trial means a clinical trial of a medical device that involves a confirmatory investigation to evaluate performance and safety for a specified intended use to satisfy pre-market regulatory requirements.
Register means the Australian Register of Therapeutic Goods maintained under section 9A of the Therapeutic Goods Act 1989.
unapproved therapeutic good means a therapeutic good yet to be entered on the Register.

Part 2—Determination that phase 0, I, II, III, pre-market pilot stage, and pre-market pivotal stage clinical trials are core R&D activities