- Clinical trials are used to find new medicines and treatments
- Joining a clinical trial may give you access to new treatments that aren’t normally available in Australia
- Talk to your doctor about the benefits and risks of joining a clinical trial
What is a clinical trial?
A clinical trial is a research study that tests new ways to prevent, detect, treat, or manage various health conditions and diseases.
The treatment being tested may be:
- a pharmaceutical drug
- gene or cell therapy
- medical device
- lifestyle program to manage disease
A clinical trial helps answer important questions about what works best for people and encourages further research.
Why would I take part in a clinical trial?
Clinical trials lead to new medical discoveries that help people live longer and with less pain and disability. Taking part in a clinical trial helps to advance medical knowledge and can lead to improvements for your health or other people’s health. Taking part allows you to have an active role in your treatment.
If you have liver disease, taking part in a clinical trial may give you access to new treatments that aren’t normally available in Australia.
Many clinical trials of new treatments involve some people being treated with a placebo (a substance without active ingredients). This is essential to allow researchers to test whether the treatment they are studying works for everyone.
Whether you get the new drug or a placebo, it’s been shown that taking part in a clinical trial is still of benefit to you. This is because you will receive high quality care and close monitoring by the study team.
Are clinical trials safe?
If you are interested in taking part in a clinical trial, your healthcare team will give you information about the known risks and possible benefits of the treatments and procedures involved the trial.
All treatments can have side effects, whether they are already approved and available or they are being studied in a clinical trial.
People who take part in a clinical trial are closely monitored. If there are problems with the new treatment being tested, action is taken quickly.
The conduct of clinical trials must be ethical. They must conform to the Ethical Principles of the Declaration of Helsinki and to international Good Clinical Practice guidelines.
Before a clinical trial can start, it needs to be approved by an independent ethics committee and follow guidelines set by the National Health and Medical Research Council (NHMRC).
You will be informed of any new information that comes out during the course of a trial.
Who can take part in a clinical trial?
People volunteer to take part in clinical trials. In many studies, the researchers look for volunteers who are healthy or who have common health conditions, such as fatty liver disease, liver cancer, or hepatitis B. Some clinical trials are focused on rare or difficult to treat conditions.
Each research study has its own guidelines about who can or cannot take part. This is called ‘eligibility’. The factors that allow someone to take part in a clinical trial are called ‘inclusion criteria’, and the factors that disqualify someone from taking part are called ‘exclusion criteria’.
People are allowed to take part based on things such as their age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Sometimes certain characteristics, such as age or gender, may prevent people from taking part.
You may need a series of tests, such as blood tests, to check you are eligible and monitor your progress.
How can I find a clinical trial?
There are thousands of clinical trials being run throughout the world. Your doctor may be aware of opportunities in your area or you can talk to support groups for your condition.
Clinical trials for people with liver disease may be listed on the ClinTrial Refer website or App.
The Australian New Zealand Clinical Trials Registry is an online registry that allows you to search for clinical trials currently available in Australia and New Zealand. You can search the registry by location, disease or health area, and then learn who to contact for more information.
You can also search the Australian Government’s clinical trials website, Australian Clinical Trials or on one of the other clinical trials registries that list clinical trials in Australia, New Zealand and some other countries.
Any health professional involved in your care can provide you with general information about clinical trials. This includes your GP, specialists, or nursing or allied health professionals.
Support groups or consumer health organisations are also good sources of information on clinical trials and may be able to put you in touch with others who have taken part in a clinical trial.
To find out more about clinical trials in Australia, visit:Australian Clinical Trials Medicines Australia Consumer Guide to Clinical Trials
Australian Government. Australian Clinical Trials. https://www.australianclinicaltrials.gov.au/what-clinical-trial/who-can-be-part-clinical-trial
Medicines Australia. Clinical trials. https://www.medicinesaustralia.com.au/policy/clinical-trials/