Clinical Trial frequently asked questions
Below we have some answers to questions we are frequently asked related to clinical trials at CAHS
Why should I get my clinical trial studies done in Australia?
Australia is home to some of the world’s best researchers and health professionals. There is a world-class research infrastructure and a stable socio-political environment. There is a simple and efficient regulatory system. Australia has one of the most diverse multicultural populations in the world, making the results of your study applicable worldwide.
What is the advantage of conducting a study at CAHS?
CAHS has performed groundbreaking patient-orientated clinical research across all paediatric disciplines. CAHS has high quality clinical research facilities with state-of-the-art equipment. For more details, please refer to the CAHS-Clinical trials webpage.
Can you conduct trials in all fields?
We conduct trials across all paediatric disciplines. We will openly and honestly discuss our capabilities with you in the initial stages of setting up a study.
Can you help us with the design of the clinical trial?
For a commercial study, the sponsor is responsible for designing the protocol and other relevant documents. For PI initiated trials, a research team at CAHS is available to support the design.
How quickly can you conduct your clinical trials?
Our processes ensure the studies we conduct are done in a timely manner, without compromising the quality of a study. Depending on the sample size and the inclusion/exclusion criteria, most studies are completed within a year after receiving HREC and site approval.
Do you obtain ethics and governance approval for your trials?
Research projects that happen at a CAHS site, which includes Perth Children’s Hospital, Community Health, Mental Health and Neonatology, must be submitted, reviewed, and approved by a WA Health or NHMRC certified Human Research Ethics Committee (HREC) and the CAHS Research Governance Office (RGO). CAHS HREC is certified as Lead HREC under NMA and can review and approve projects across public health organisations across multiple Australian jurisdictions.
The centralised office for the CAHS HREC and RGO is at Perth Children’s Hospital. The team in this office facilitate 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, and applications can be submitted to both review streams simultaneously.
Do you support sponsored clinical trials?
Yes, CAHS supports commercially sponsored clinical trials. In the research year 2023-24, CAHS had 169 approved clinical trial studies, which includes 20% of commercially sponsored studies.
How do you complete specimen collection and analysis for your clinical trial?
Most of the specimen collections are completed at the clinic during your study visits. The samples are sent to the central laboratory facility contracted by the sponsor for further analysis. Unscheduled visit samples during the study can be collected at large commercial pathology centres, with whom we have established a relationship. They are (NATA)-accredited laboratories with collection centres throughout Australia. Typically, registered phlebotomists collect blood samples for us. Where possible, we prefer to use the services of this organisation as it allows study volunteers to visit their nearest collection centre rather than travel to a specific location.
How do you recruit your study volunteers?
The primary source will be the referral doctor or the specialist who will inform their patient pool about a potential study. If required, the PI will circulate the study information to the doctors working in the same department across other WA hospitals.
How much do your trials cost?
There is no fixed cost for running a clinical trial study. It depends on several factors like study design, phase of the study, timeline, sample size, and outcome measures that will be used. Specialised testing and analysis will add to the costs. Please refer to our brochure for an estimate of the cost involved in running a commercial study.
Do you organise clinical trials insurance?
Yes, the sponsor is responsible for providing valid insurance/indemnity. We ensure there is valid insurance/indemnity throughout the study.
What are your arrangements on intellectual property (IP)?
For a sponsored study, the IP rights remain with the company itself.
Do you list 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 trial registry. Researchers must ensure that 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 registration are required in RGS.
All our trials are prospectively listed on the Australian and New Zealand Clinical Trials Register (ANZCTR) and Australian Clinical Trials.
Whom should I contact in CAHS to set up a clinical trial study?
Please contact CAHS.Clinicaltrials@health.wa.gov.au and the team will be in touch to assist you further.
To learn more about the clinical trial departments and facilities at CAHS, refer to our clinical research webpage.