Clinical trials for medication, treatment and devices are divided into phases.

Trial phases for new medication and treatments

Medication and treatment clinical trials are divided into four phases.  All new medications must be tested in phase I, II and III studies before they are approved for use by the public.

Phase I trials
Phase II trials
Phase III trials
Phase IV trials
Diabetes and Endocrinology research nurse in Clinical Trials Centre
Research nurse in Clinical Trials Centre

Trial phases for new medical devices

Medical device clinical trials are divided into four phases.

First-in-human or pilot phase
Traditional feasibility
Pivotal phase
Post-market phase
Research staff in lab
Staff in lab

Monitoring of clinical trials

All clinical trials are closely monitored throughout the process to ensure effectiveness, safety and compliance.  

Regulatory guidelines and organisations

All clinical trials are conducted in accordance with the:

These guidelines state the requirements for:

  • Documentation
  • Protocols
  • Indemnities
  • Informing participants
  • Obtaining consent
  • Reporting adverse (bad) events

In Australia, clinical trials are also conducted in accordance with the National Statement on Ethical Conduct in Human Research. This document provides guidance on ethical issues in human research.

All clinical trials must be approved by Human Research Ethics Committee (HREC) before they can start.


Sponsors monitor clinical trials closely to ensure that all procedures are being completed correctly. Sponsors monitor the trial data to detect any potential side effects of the new treatment as soon as possible.

Data Safety Monitoring Board (DSMB)

Most phase III studies have a Data Safety Monitoring Board (DSMB), which is a group of independent experts who periodically review the trial data for safety, effectiveness and trial conduct and progress. The DSMB makes recommendations about whether the trial should continue, be modified or terminated.

The Office for Research

The RMH's Office for Research is responsible for the governance of all research conducted at the RMH. Investigators and sponsors report regularly on the conduct of the trial and how it is progressing.

Diabetes and Endocrinology research nurse with patient in Clinical Trials Centre
About clinical trials

We need clinical trials to prove that new treatments are safe and effective for people to use. They are essential to the discovery of new medications and devices, neither of which can be approved for use in Australia without clinical trials.