Clinical trials

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.

We have endorsed the implementation of the NCTGF in Metro South Health.

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:

• our Clinical trials guideline
• the Australian Clinical Trial Handbook
• How clinical trials work
• Apply for ethics approval for a clinical trial
• Research Governance related to Clinical Trials Principles, regulations and governance of clinical trials
• Good Clinical Practice (GCP) for clinical trials in Australia

Finance and budgets

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

Clinical Trial Notification (CTN)

Clinical trials that involve the use of 'unapproved' therapeutic goods, including use of an approved drug or device in a manner (dose or cohort) that is not ARTG approved, must register using the Clinical Trial Notification (CTN) scheme. The CTN Scheme is a notification process to the Therapeutic Goods Administration (TGA).

CTN process

The process for CTN approval involves both ethics and governance.

• The eCTN registration is completed online and uploaded with the HREA via ERM for HREC review.
• When the HREC approval letter is received, the eCTN can be lodged with the TGA.
• Once received, the CTN Acknowledgement letter must be submitted to the Metro South research governance office via ERM either with the SSA submission or as a post authorisation notification (PAN) depending on the status of the clinical trial approvals.

For more information, read the Clinical trial notification (CTN) form – user guide.

CTN details

Clinical trials that include a Metro South site must include the following Metro South Health approving authority details on the eCTN registration form.

Approving authority details

For all Metro South Health sites listed on a CTN, please insert the following approving authority details:

HREC details

If the Metro South HREC has approved the study, please insert the following details. If the study has been approved by an external HREC, please contact that HREC for their details.

Site name

Each Metro South site/facility involved in the clinical trial must be listed as a separate entry in the CTN. For example, the CTN for a clinical trial involving both the Princess Alexandra Hospital and Logan Hospital will need to include two separate entries, even though they have the same Approving Authority details. Please ensure that the street address of the site is included in the 'site physical location' section of the CTN.

Example: 

Site specific PICFs

Site specific PICFs should include the following Metro South research governance contact details:

Clinical Research Facility

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.

Using teletrials for research

Queensland Health provides information on teletrial site requirements and how to set up a teletrial.