Information for GPs

AusTrials is Australia’s leading clinical trials and research organisation and has worked with most of the major pharmaceutical companies within Australia. We operate under the regulatory oversight of the TGA and adhere strictly to the ethical and professional standards set out in ICH-GCP and the National Statement on Ethical Conduct in Human Research. All of our trials and protocols are submitted for review and approval by an independent and highly-regarded Human Research Ethics Committee.

Clinical trials are a key part of developing and proving new therapies and treatments for disease, and we are proud to provide access to clinical research opportunities in Australia.

AusTrials conducts clinical trials in a wide range of therapeutic areas, with clinical trial opportunities to suit patients from a variety of backgrounds, including children, seniors, and healthy volunteers.

AusTrials would like to hear from GPs interested in referring patients to trials and/or conducting research with AusTrials through our Phase IV GP Trials program. AusTrials offers remuneration for your time and effort in the referral process. For more information on clinical trials from AusTrials, please register here:

Clinical Trials – Benefits for Patients

Clinical trials offer benefits to eligible participants that may not be otherwise available:

• Patients may be able to access the most up-to-date medical treatment for an illness through a clinical trial.
• Participation offers potential access to new or existing medical treatments at no cost and under the close care and supervision of medical professionals.
• Clinical trials may offer remuneration for the time and effort required.

AusTrials study coordinators will carefully screen all potential volunteers for each study. Patients participating in a clinical trial will be able to continue their care with their regular GP. In some cases, the study treatments will be complementary to their current treatment.

Clinical Trials for Children

Clinical trials for children help develop safe and effective treatments that are better suited to the needs of a child. Treatments for childhood illness or disease must be specifically formulated to meet the needs of the children who need them. As such, many clinical trials for children are for variations of treatments that are already available for adults. These trials are designed to help researchers monitor the treatment in children and understand how children respond to the treatment.

Frequently Asked Patient Questions

Are trials safe?

Clinical trials test the safety and effectiveness of a study medication. As with all medications, there are risks of adverse reaction to the study medication. Ethically approved clinical trials are carefully designed to minimize the risks and ensure the safety of study volunteers.

• Study co-coordinators carefully interview each potential volunteer about their health and any current treatments to determine if the study is right for the volunteer.
• Trial specific information is provided to each volunteer, explaining the study, what to expect, and when to contact a health professional.
• Volunteers are closely monitored by experienced health professionals and researchers throughout the course of the study.
• Volunteers are in contact with researchers to report on their overall health and well-being and to voice any questions or concerns.
• Volunteers are able to continue care with their regular GP or care provider.

Are there different types of clinical trials?

There are four different groups or Phases of clinical trials. As a study medication goes through each phase, researchers begin to know more about the medication, how patients respond to the medication, and any possible adverse reactions to the medication. Each Phase has strict regulations about how trials are to be conducted and conditions for volunteer participation. AusTrials primarily runs Phase II, III, and IV trials.

• Phase I Trials are when a drug is tested in humans for the first time. The testing at this phase looks at the safety of a treatment – or any adverse side effects – as well as assessing dosing levels. These studies are generally done with a small group of healthy volunteers over several months.
• Phase II Trials test the efficacy of a treatment – or how well it works. These studies are generally done with a larger group of volunteers who have a specific illness. Usually there is one group of patients that receives the study treatments and another group that receives either a placebo or the current standard treatment for the illness.
• Phase III Trials are large scale studies often involving several thousand volunteer patients. Phase III allows researchers to gain a better understanding of the benefits and possible adverse reactions to the treatment on a larger scale and over a longer period of time. After successfully completing Phase III trials, a company can submit the study information to get approval to market the treatment.
• Phase IV Trials are conducted after a treatment has been approved for sale. Phase IV allows companies and researchers to continue to monitor the treatment as well as evaluate how it compares to other treatments available.

Are there trials available for healthy patients?

As each treatment being studied is different, each clinical trial has different requirements for participation and offers different benefits to volunteers. While some studies require only patients with a specific illness or of a certain age or gender, some studies may be looking for healthy volunteers from various backgrounds (such as flu-shot studies, or contraceptive pill studies).

What about my current treatment?

Some trials may allow you to continue with your current treatment, while other trials may interfere with other medical treatment you are receiving. It is important to discuss any medications you may be taking with the study coordinator and determine how participating in the trial may impact your treatment.

What if I get a placebo?

Generally, there will be no way of knowing whether a patient will receive the new study treatment, a standard existing treatment, or a placebo. As each trial is different, it is important patients speak with the study co-coordinators and their doctor to determine how participating in a trial might conflict with or complement their current treatment. There is no reason a patient should put their health at risk.

In some cases, patients who are given a placebo during a trial will be given the study medication at the end of the trial if it is determined to be effective. Should patients find that their well-being is impacted by participation, they may withdraw from the trial at any time.

What about allergies?

If a patient has any known allergies – or has ever had an adverse reaction to medication– it is important to discuss this with the clinical trials staff before joining a trial. Only patients who meet all the study criteria will be permitted to participate.

Information for Health Professionals

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