Photo: Effective drugs
or other treatments often depend on patients taking part in
clinical trials. (iStockPhoto/anna1311)
Have you ever considered being part of a clinical trial?
Cancer treatments, joint replacements and mental health
interventions are just some of the many trials underway in
And while you might have thought clinical trials were reserved
exclusively for patients with life-threatening conditions,
participants in perfectly good health are needed too.
The National Health and Medical Research Council (NHMRC) is
calling on Australians to register their interest in being part of a clinical
Types of clinical trials
Treatment trials test new treatments,
new medicines or combinations of medicines, or other new
therapies such as surgery, the use of new medical devices
or new approaches to surgery
Diagnostic or screening trials evaluate
tests or procedures to diagnose and detect diseases or
Prevention trials test new ways to
prevent disease including medicines, vaccines, vitamins
or changes to diet, lifestyle or behaviour
NHMRC director of clinical trials Dr Gordon McGurk said there
was a great need for volunteers.
“The more people that know about the range of trials underway
the better,” he said.
“It’s difficult to expect general practitioners to tell every
patient about the clinical trials available because they just
don’t have time.
“Unless you ask, chances are you won’t be told.”
Trials can involve people of all ages; children, the elderly
and people with all types and stages of a disease or condition.
“Healthy volunteers go in these trials too and they are
absolutely essential,” Dr McGurk said.
“There are also many people who are struggling to find a cure
for their particular condition and they will weigh up a side
effect against a possible life-changing nature of a treatment.”
The different phases of clinical trials explained
Clinical trials occur in different phases — phase one tests a
new biomedical intervention for the first time in a small group
of people to evaluate safety and identify side effects.
Clinical trial interventions include:
- experimental drugs
- cells and other biological products
- medical devices
- surgical and other medical treatments and procedures
- psychotherapeutic and behavioural therapies
- health service changes
- preventive care strategies
- educational interventions
“One always has to have pre-clinical data before you actually
get to the human stage,” Dr McGurk said.
Phase two involves are larger group (several hundred) to assess
efficacy and further evaluate safety.
“You have a control group who don’t receive any treatment as
well as the group that is undergoing the treatment,” Dr McGurk
The third phase can involve up to several thousand participants
by comparing the intervention to other standard or experimental
Phase four studies are done after an intervention has been
marketed to collect information about any adverse effects over
a longer period.
is making a major contribution to the development of
therapeutic anti-cancer agents. (Supplied:
Professor Chris Parish, an immunologist and cancer researcher
at the John Curtin School of Medical Research, is in the third
stage of a clinical trial for an anti-cancer drug known as
“I’ve been through the process of making a discovery,
developing a drug, a vaccine and then trying to translate it
into a clinical trial,” he said.
“It’s quite a tedious process.”
Professor Parish said a clinical trial process could take up to
“As a researcher you get very excited about your new
discovery, but it does take a hell of a long time for that
discovery to eventually be in the clinic.”
Professor Parish said factors that had nothing to do with
science would often determine whether a new discovery
“Science can be perfect all the way through, but if it’s
decided that the cost is too great for the benefit, for
example, and you can’t get a commercial partner.
“The NHMRC grants are great for starting the process but it
costs hundreds of millions of dollars eventually to get a drug
into the clinic.”
Photo: In the advanced stages
of a clinical trial, there is the possibility that some
participants are given a placebo. (ABC
Tropical North: Sophie Kesteven)
How are trials selected for funding?
Each year the NHMRC disperses around $900 million through its
medical research endowment account.
Of that, more than $100 million goes towards clinical trials.
“These trials are largely conducted by academic researchers who
might want, for example, to compare the efficacy of two drugs,”
Dr McGurk said.
“This can result in huge savings on the Pharmaceutical Benefits
Through the NHMRC’s peer review process, applications for a
trial go to a review panel which decides on the quality of the
trial and to a large extent the likelihood of it succeeding.
“In the early stages of a trial, pharmaceutical companies
aren’t necessarily interested, but once they can see the early
results then they might get involved,” Dr McGurk said.
“Often there is a very clear area of unmet need, but because
there are so many researchers who apply for trials, only some
can be funded because they are so very expensive.
“The average grant for a trial would be a couple of million