Health authorities in New South
Wales have launched a suite of initiatives that position the State as a globally
competitive destination for early phase clinical trials, which are the first
step in testing new pharmaceutical and biomedical interventions using small
groups of patients.
A key plank of the strategy is
the Early Phase Clinical Trials Framework for NSW, designed by the Office for
Health and Medical Research to speed up ethics approvals of trials and to give
industry a reliable benchmark on quality assurance.
While NSW is already noted for
the high quality of its trials, the new processes and systems ensure alignment
with best practice internationally and nationally.
“There are a number of components
and they will provide a quality framework, and an assurance system for our
sites that conduct early phase clinical trials,” says NSW Chief Health Officer Dr
“Our infrastructure in NSW is
already very high quality, but this initiative will strengthen that. Industry
can then rely on the fact that we actually have those quality controls and
auditing built in, which will give us a competitive advantage,” Dr Chant adds.
The aim is to create a consistent
process that will be attractive from an international perspective.
Better and faster pathways
The new early phase HREC (Human
Research Ethics Committee) scheme creates a clear and transparent process, with
guidelines and metrics to improve the quality and the speed at which ethics
approvals can be given for Phase I or First-in-Human clinical trials.
Whereas the previous process
required dealing with multiple ethics committees, this initiative streamlines
the process through two specialist ethics committees appointed by NSW Health –
Sydney Children’s Hospitals Network for paediatric trials, and Bellberry
Limited for clinical trials involving adults.
This will allow early phase
clinical trials to be signed off very rapidly. “They will provide safe and high
quality scientific and ethics review of all applications within 20 working
days, a significant time saving on the previous system,” Dr Chant says.
A new quality recognition scheme
will also be rolled out over the coming year. This scheme will ensure that
accredited facilities and sites that conduct early phase trials in NSW are
operating to best practice standards.
To support these trial
initiatives, and enable clinical trial capacity and capability across the
State, NSW Health has established a clinical trial support unit. This one-stop
shop will take inquiries, help people navigate the system, connect researchers,
patients and industry and help embed clinical trial outcomes into health
“The system is complex and can
seem really overwhelming,” she says. “For those with a new product or device,
who are experiencing a clinical trial process for the first time, it’s useful
to have access to people who have been involved in the process many times over”.
Why clinical trials matter
NSW Health sees the development
of its capacity to conduct clinical trials as vital, as they provide access to
“They allow new evidence to be
built and support a culture of learning and evidence-based medicine,” Dr Chant
says, with potential benefits that go beyond the trials themselves. “Having the
rigour of running trials and testing new things supports hospitals culturally,
by having a system of reflecting on evidence.”
Patients are winners too, as
those receiving treatment in hospitals with clinical trials programs do better on
average than patients attending hospitals that do not have active research
environments. “We see clinical trials being a fundamental component of health
service delivery systems,” says Dr Chant. “The trials also provide opportunities to develop new technologies and
drive economic development.”
Using big data for more personalised drug
trials are also changing thanks to new tools for patient follow-up,
particularly via data linkage and using data systems throughout the state
health network to more accurately identify populations and find suitable
patients. “We’re learning to take a genomic approach to selection
of patients, with much more sub-targeting of therapy based on genomic markers,”
Dr Chant says.
Traditional trial designs are
becoming more complex in their randomised control design, and time taken from
evidence generation to application is potentially shorter. The advent of genomics
has also opened up opportunities.
“We’re also looking at
repurposing drugs that have been used for other purposes and at how they might
be applicable to new or old conditions with a new lens of genomic data to
tailor it,” says Dr Chant.
Australia in general, and NSW in
particular, are well positioned as world leaders in the field. “Australia is
well respected and has a strong and excellent health system. It has strong
mechanisms, both in terms of ethical reviews and regulatory authorities,” she
“What we at NSW Health are doing through
our Office for Health and Medical Research is setting up a function that assists
industry. It provides a contact to both solve problems and acts as a connector
for those companies that might want to establish clinical trials in New South
By Bill Condie
Updated 1 year ago