Clinical trials can evaluate medicines, procedures, medical devices, and other health treatments. They are divided into different stages, called phases. The earlier phase trials look at whether an intervention is safe and effective, whilst later phase trials aim to test whether new treatments are better than existing treatments.

Within South Western Sydney we primarily conduct Phase II and Phase III trials.

Phase I clinical trials test a new drug or intervention for the first time, in a small group of people. The aim is to evaluate how safe the medicine is, how it works, and how well tolerated it is. These trials are generally very short, and have a high degree of supervision.

Phase II trials are conducted on a small group of people have a specific medical condition. The aim is to assess whether the intervention is safe and effective. These trials are also closely supervised.

Phase III trials generally involve many thousands of people from around the world. The aim is to show that the intervention is safe and effective for the treatment of a specific medical condition. These trials are monitored both locally and at an international level.

Phase IV These trials are done after the drug or intervention is approved by the Therapeutic Goods Administration (TGA). The aim of these trials is to obtain further information about the drug or intervention in widespread clinical practice.

There are several ways to search and find out about clinical trials:
– Your doctor may suggest one
– A friend, relative, or member of a support group may mention it.
– Or you can do research to find a clinical trial that is appropriate.

You can search for Australian Clinical Trials here.

Once you find out about a clinical trial, you’ll need to find out if you are eligible to participate. All clinical trials have a set of standards to ensure that there is a consistent group of participants.

If you are thinking of being part of a clinical trial, you should know as much as possible about the trial and your involvement in it. You can discuss your questions with your doctor and with the research team. You may also find some of the answers to your questions in the participant information and consent form.
When you plan to discuss participation
• consider taking a family member or friend along for support and for help in asking questions or recording answers
• plan what to ask ahead of time, but don’t hesitate to ask any new questions that you think of while you’re there
• write down your questions in advance to make sure you remember to ask them all
• write down or record the answers, so that you can review them whenever you want
• remember that you can ask further questions to the team running the trial at any time
• remember that you can withdraw from the trial at any time and resume other treatment, if that is recommended.

Here are some questions that you may want to ask:
About the trial
• What is the aim of the trial and how will it help people?
• Has the intervention been tested before and, if so, what was the outcome?
• Will the trial use a placebo (a ‘dummy’ treatment), standard care or another established intervention as the control to compare with the new intervention?
• Who is funding the trial?
Your involvement
• How might this trial affect my daily life? How much of my time will be needed?
• What kinds of tests and experimental interventions are involved?
• Will I have to complete questionnaires or keep a diary?
• Will I need to spend time in hospital?
• Will I need to take time off work or school?
• Where will the trial be conducted and will I have to travel to be part of it?
• Will I be able to take my regular medications while participating in the trial?
• How long is the trial expected to last? How long will I have to be part of it?
• What will happen if I stop the trial intervention or leave the trial before it ends?
• Who will be in charge of my care? Who can I contact for support and information during the trial? Will someone be available 24 hours a day?
Risks
• What are the risks of taking part in this trial? What are the possible side effects of the trial intervention?
• How do the possible risks, side effects and benefits in the trial compare with my current treatment or care?
• If people receiving one intervention in the trial respond much better than people receiving the other intervention or standard care, will all participants be given access to the more effective intervention?
Costs
• Who will pay for the experimental intervention?
• Will I be paid to participate in the trial?
• Will my expenses be covered?
• If there are complications that arise from the trial, who is responsible for paying for any costs that are associated with them?
After the trial
• What follow-up care is available after the trial?
• How long will it be before the results of the trial are known?
• How do I find out the results of the trial?
• Will I have access to the experimental intervention after the trial if I wish to continue with it?