What is a clinical trial?

A clinical trial is a form of clinical research where people volunteer to evaluate new treatments, interventions, or tests. These are aimed at preventing, detecting, treating, or managing different diseases or medical conditions. They're structured to answer specific questions about possible new treatments or new ways of using existing treatments. The purpose of clinical trials is to determine the safety and effectiveness of new drugs or treatments.

Clinical trials include but are not limited to:

  • surgical and medical treatments and procedures
  • experimental drugs
  • biological products
  • medical devices
  • health-related service changes
  • preventative strategies
  • educational interventions
  • lifestyle or behavioural interventions.

We're involved in a range of clinical trials including:

  • commercially sponsored trials
  • collaborative trials with multi-centre networks
  • investigator-initiated trials.

Australia has its own regulatory requirements for clinical trials. The Therapeutic Goods Administration (TGA) is responsible for administering the Therapeutic Goods Act 1989.

Read more about taking part in a clinical trial.

National Clinical Trials Governance Framework

The National Clinical Trials Governance Framework (NCTGF) was developed in 2022 by the Australian Commission on Safety and Quality in Healthcare.

The NCTGF aims to ensure that clinical trials are done safely and with high quality to improve health outcomes for patients and communities. The framework includes standards from the National Safety and Quality Health Service (NSQHS), which are already used in hospitals in Australia. These standards will also now apply to clinical trial services.

After a pilot phase, clinical trial services are now assessed using a maturity scale based on the framework. This includes using a list of actions in the NSQHS and:

  • outlining the roles and responsibilities of everyone involved in clinical trials
  • the strategies that may be used to meet these actions
  • examples of the type of evidence that may be used to show they’ve met the actions.

Because health services already meet safety and quality standards, they can build on their existing processes to prepare for the assessment.

Read more about the National Clinical Trials Governance Framework on the Australian Commission on Safety and Quality in Health Care website.

How we’re implementing the governance framework

We’ve endorsed the implementation of the NCTGF in Metro South Health. Watch our recent information session about Implementing the National Clinical Trials Governance Framework in MSH.

Benefits of doing a clinical trial with us

Before you can start a research project you need to apply for ethics approval and site specific assessment authorisation.

We have some of the world’s best researchers and health professionals, as well as world class infrastructure for clinical trials. This includes a multi-use research facility.

We also have a diverse range of people willing to take part in clinical trials and a simple and efficient regulatory framework.

Because of these, we’ve had many big pharmaceutical and medical technology companies invest in our clinical trials over the last thirty years.

For more information, read:

Finance and budgets

We have a site fee schedule tool to help researchers develop budgets for their studies. Email MSH-Research@health.qld.gov.au for more information about using the tool.

Clinical Research Facility

The Translational Research Institute Clinical Research Facility (CRF) at Princess Alexandra Hospital, offers specialised services and resources to support research and clinical trials involving new medicines and medical equipment.

Established in December 2014, the CRF has facilitated over 250 research studies involving thousands of individuals. It has comfortable and spacious rooms for participants. The CRF also has full access to medical and emergency services at Princess Alexandra Hospital.

Read more about TRI on the Translational Research Institute website.

Clinical Trials Hub

Health Translation Queensland’s Clinical Trials Hub provides practical resources and tools for clinical trial teams to effectively plan, manage and track the progress of their clinical trials.

Clinical trials online training

Australian Clinical Trials Education Centre (A-CTEC) - online training

A-CTEC's learning management system (LMS) includes online courses, live webinars and other education tools to help build knowledge of clinical trials.

Last updated: September 2024