For industry and sponsors: clinical trials
Perth Children’s Trials Centre (PCTC) is Western Australia’s flagship centre for paediatric clinical trials.
Centrally located at Perth Children’s Hospital – WA’s specialist paediatric hospital – and in the heart of WA’s medical and research precinct, we are a single point of contact for all paediatric clinical trials.
We offer collaborators a streamlined, scalable, and sponsor-ready environment that combines operational efficiency with strong governance and participant access.
Our team
PCTC is staffed by experienced research professionals who provide specialised support in the form of clinical trials co-ordination, business management, ethics and governance services, nursing and pharmacy.
Our facilities
We have a dedicated hospital-grade research outpatient clinic that includes:
- 12 consultation rooms
- a dedicated treatment room and access to the Day Treatment Unit for more invasive procedures
- 2 laboratory spaces, including a PC2 facility for advanced therapies
- 2 purpose-built rooms for respiratory and stress electrocardiograms
- a clinical trials pharmacy to manage clinical trial investigative products
- a room with 2 infusion chairs.
Beyond our research clinic, PCTC runs clinical trials throughout Perth Children’s Hospital in areas such as the emergency department, oncology ward and surgical theatres.
A Statewide service
As part of the wider Child and Adolescent Health Service – Western Australia’s only dedicated health service provider for infants, children and young people – PCTC serves all the children and young people of Western Australia.
We welcome contact from industry and sponsors interested in working with us to improve health outcomes for children and young people.
What are some of the advantages of conducting a clinical trial in Australia?
Australia is home to many high-performing researchers and health professionals, who operate within a modern and well-equipped healthcare system.
Australia offers a stable socio-political environment and has a simple and efficient regulatory system. With one of one of the world’s most multicultural populations, it is also an ideal place for recruiting diverse study samples.
What is the advantage of conducting a study at CAHS?
At the Child and Adolescent Health Service (CAHS) our researchers perform quality, patient-orientated clinical research across all paediatric disciplines.
We also offer dedicated onsite clinical research facilities which are modern and well-equipped.
Can you conduct trials in all fields?
Yes, we conduct trials across all paediatric disciplines and will discuss our capabilities openly and honestly with you from the outset.
Can you help us design a clinical trial?
In commercial studies, sponsors are responsible for designing protocols and other relevant documentation. An inhouse research team is, however, available to support with the design of investigator-initiated trials.
Do you obtain ethics and governance approval for your trials?
Yes, all research projects undertaken at CAHS sites – which include Perth Children’s Hospital, Community Health, Mental Health and Neonatology – must be submitted, reviewed, and approved by a recognised Human Research Ethics Committee (HREC) and our own Research Governance Office (RGO). Our HREC is certified as a Lead HREC under the National Mutual Acceptance (NMA) scheme, which enables projects to be reviewed and approved across public health organisations throughout Australia and across multiple Australian jurisdictions.
The centralised office for the CAHS HREC and RGO is at Perth Children’s Hospital. The team in this office facilitates the ethical and governance review of proposed projects and monitoring of approved research across CAHS sites.
Research projects at a CAHS site require both HREC and RGO review and approval. Applications can be submitted to both review streams simultaneously.
Do you support sponsored clinical trials?
Yes, CAHS supports commercially sponsored clinical trials and typically has around 180 trials underway at any one time, about 20 per cent of which are sponsored commercially.
How do you recruit your study participants?
Most recruitment is via doctor or specialist referral, with the referrer informing their patient pool about a potential study. Where appropriate, a PI will circulate study information to doctors working in corresponding departments across other Western Australian hospitals.
How much do your trials cost?
There is no fixed cost for running a clinical trial. A range of factors such as study design, study phase, timeline, sample size and whether specialised testing and analysis is needed, will determine the ultimate cost. Speak to our Clinical Trials Liaison officer to discuss your project.
Do you register your trials?
Yes, trial registration involves posting the details of a trial’s design, conduct and administration on a publicly accessible database known as a clinical trials registry. The sponsor (or Principle Investigator for an Investigator initiated trial) must ensure their clinical trial is registered in a publicly accessible database before recruitment of the first participant.
Trial registration is important for participant recruitment because it allows people interested in participating in a clinical trial to search for relevant clinical trials on a single website. Registration also assists health professionals to identify relevant trials for their patients.
Researchers should register trials as early as possible and ensure information such as contact details and trial status is kept up to date. The details of trial registrations are required by our Research Governance Service (RGS).
All CAHS trials are listed prospectively on the Australian and New Zealand Clinical Trials Register (ANZCTR) and Australian Clinical Trials.
Is the data from Australian clinical trials applicable to U.S regulatory submissions?
Yes, clinical trial data from Australia is highly regarded and accepted by international regulatory agencies, including the U.S. Food and Drug Administration (FDA). Australian clinical trials adhere to ICH-GCP guidelines, ensuring the quality and integrity of the data meet global standards.
How do I obtain a CTN (Clinical Trial Notification) acknowledgment?
To obtain a CTN acknowledgment, sponsors submit the necessary trial documentation to the TGA via their online portal. The Australian sponsor is responsible for submitting the CTN, once the trial has ethics approval from a HREC. A clinical trial is deemed to have been notified (and thus may commence) once the CTN form has been submitted with payment of the relevant fee to the TGA. While it is not necessary to wait for it, the TGA Acknowledgment of the CTN is typically received within days of submission.
Does CAHS use standard operating procedures to share with Sponsors?
Yes, CAHS has standard operational procedures for the approval of research. This document provides CAHS employees and other external research colleagues – including students – the requirements for ethics review and approval of research involving human participants within CAHS. This document outlines the responsibilities and functions of the various stakeholders involved in research. It is designed to promote good practice, ensuring that CAHS complies with the Australian Code for the Responsible Conduct of Research, 2018 (‘the Code’) and the National Statement on Ethical Conduct in Human Research 2023 (National Statement).
For the current SOPs please refer to Child and Adolescent Health Service Standard Operational Procedures for the approval of research.
Who should I contact at CAHS to set up a clinical trial?
Please email our clinical trials team and a team member will get in touch to assist you further.
Visit Research across our departments to learn more about CAHS’ research activity.