Participant Information

A clinical trial is a scientific study of a new drug or device involving human volunteers. Clinical trials are a test of the effectiveness of the new treatment and its safety.  Clinical trials are also used to find new uses for existing medicines.

Clinical trials help confirm if the treatment being studied will work, what the side effects are, how well they are tolerated and what the correct dose of a medicine should be. This helps doctors to decide if the new treatment is more effective and/or safer than existing medicines or treatments. A clinical drug trial is commenced only after results of testing in the laboratory and in animals has been completed with positive results.

Without clinical trials, new medicines and medical devices cannot be approved for use in Australia.

All new drugs must be tested in Phase I, II and III studies before being approved for use by the public.

Phase I trials

In Phase I trials new drugs are tested in a small group of people after extensive laboratory testing. The aim is to find out how safe the medicine is, how it works and how well it is tolerated. Typically these trials are very short and very tightly controlled with a high degree of monitoring of participants.

Phase II trials

Once a drug has been successfully trialled in a Phase I study it is then tested again in a small number of people who have the disease that the drug is being developed to treat. The aim of Phase II trials is to assess the best dose of the drug in regard to its effectiveness and safety. Typically these trials are short and closely supervised. Participants are closely monitored.

Phase III trials

When a Phase II trial of a drug shows that the drug has potential benefits that outweigh the risks (side effects) the drug is tested in a Phase III trial. These trials involve many participants from around the world. The aim of Phase III trials is to show that the new drug is effective for the treatment of a medical condition and safe to use.

To ensure that the results of the trial are correct it is necessary to include two groups in the trial. The difference between the two groups is that one group will have the new drug and the other group will not. To do this a placebo may be used which looks identical to the new drug but does not contain any medicine. Participants are randomly assigned to either of the groups. Neither the participants nor the research staff know who is receiving the new drug or placebo. Both groups are then monitored so that scientific analysis can determine if the drug is effective.

Phase IV trials

Phase IV trials are done after the drug is approved by the Therapeutic Goods Administration (TGA). The aim is to obtain further information about the drug or to compare approved drugs to find out which treatment is better.

 

If you are interested in participating in a clinical trial speak to your doctor.

There are a number of advantages to participating in clinical trials including:

• Early access to new medicines not otherwise available
• Obtaining the clinical trial medicine at no cost during the trial
• Receiving close monitoring of your health; and
• Contributing to the development of future life-saving or life-enhancing treatments.

However participation in clinical trials is not without downsides. You may experience side effects from the trial treatment or procedures. The treatment may not work for you. You may be placed in the control group and therefore not receive the new treatment. You may need to visit the hospital more frequently and/or stay in hospital longer for monitoring of your condition.

Before deciding whether to participate in a clinical trial you will be given a full explanation of the clinical trial in writing and verbally. The explanation of the study will include:

• Information about the trial medication/device and the testing that has already been done
• Possible risks and benefits of the new treatment
• Type, frequency and risks of any required medical tests or procedures
• How participation in the study differs from the care you would receive outside of the trial
• Alternative treatment options and treatments that you will not be able to have during the trial.

Participating in any research is voluntary and you will receive appropriate care for your condition whether or not you choose to participate in the study.

The following apps and databases may assist you in locating relevant clinical trials:

• Clin Trial Refer is an app that links doctors and patients with clinical trial sites
• ClinicalTrials.gov is a database of privately and publicly funded clincial studies conducted around the world
• Australian New Zealand Clinical Trials Registry is a database of registered clinical trials.

By the time a drug reaches the clinical trial it has already been extensively tested for side effects however there may be additional side effects that were unknown or unforeseen. It is not possible to predict in advance if side effects will occur but, if they do, appropriate care will be provided.

All clinical trials are conducted in accordance with the National Health and Medical Council and NSW Health policies. Your information will be kept confidential and you will not be able to be identified in any publication of the results. Your consent to share your information with any other organisation will be obtained before information is released.

It is important to ask for an explanation on any information that you do not understand. Some questions you might ask before participating in a clinical trial include:

• What testing has already been done on the new drug/device?
• How many people has the new treatment been tested in to date?
• How does participation in the study differ from the standard treatment for my illness?
• Why is the new treatment expected to be better than the standard treatment?
• What will happen if I develop a side effect to the new treatment?
• How might participating affect my daily life?
• How long will I participate in the trial?
• What will happen after the trial is finished?
• If I benefit from the new treatment will I still be able to receive it after the trial has finished?