About clinical trials
Clinical trials are a very important part of the research process. Without clinical trials, new treatments and medicines cannot be approved for use in Australia.
Why are clinical trials so important?
Clinical trials are at the core of our patient care. They are essential to the discovery of new drugs and devices for a range of health conditions, and provide patients with access to new interventions. In this video, our leading researchers talk about why clinical trials are so important.
What is a clinical trial?
A clinical trial is a research study where people can volunteer to test new treatments, devices or tests to help prevent, detect, treat or manage diseases or medical conditions. These treatments, devices or tests are known as interventions.
with the trial coordinator to safely deliver a brand new cancer drug to patient Liza.
Interventions can include:
- experimental drugs
- cells and other biological products
- vaccines
- medical devices
- surgical and other medical treatments and procedures
- psychotherapeutic and behavioural therapies
- health service changes
- preventive care strategies
- education
Clinical trials generally involve testing:
- New interventions - by testing how people respond to the new intervention and what side effects might occur. This helps to determine if a new intervention works, is safe and is better than the interventions that are already available.
- Existing interventions - by comparing existing interventions and either testing new ways to use them or observing how people respond to other factors that might affect their health (such as dietary changes).
What is a clinical trial?
Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions.
Why do we need clinical trials?
Clinical trials are necessary to prove that a new intervention is safe and effective for use in humans.
Clinical trials help confirm if the intervention 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 intervention 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 has been completed with positive results.
Without clinical trials, new medicines and medical devices cannot be approved for use in Australia.
How are clinical trials approved?
Clinical trials must be ethically and scientifically reviewed by a Human Research Ethics Committee (HREC) before commencing. The HREC is a group comprising health professionals, researchers, lawyers and members of the public.
Who initiates clinical trials?
Clinical trials may be initiated by a drug or device company that has developed a new intervention. They are called the sponsor of the clinical trial and must be an Australian business. Sometimes the intervention has been developed by an overseas company. In these cases, an Australian company is contracted to act as the sponsor on behalf of the international company. The sponsor provides funding to the hospital to cover the costs of conducting the clinical trial.
Clinical trials may also be initiated by medical research organisations and individual or groups of health professionals, such as doctors and nurses. These trials may be funded by a research organisation, a grant from research funding bodies, or by the hospital itself.
Who runs a clinical trial?
Each clinical drug trial and most device trials are led by a doctor who is referred to as the Principal Investigator. The clinical trial team includes doctors and nurses, pharmacists and other health professionals. The clinical trial team is responsible for conduct of the whole trial.
What are Phase I, II, III or IV clinical trials?
There are four different phases of a clinical trial. Each phase is represented by a roman numeral.
Find out more about what happens in each phaseHow can I participate in a clinical trial?
Firstly, you need to find out if there are any clinical trials being conducted that you are suitable for:
- You may see advertising around the hospital - current clinical trials may be advertised in the hospital or even in the media. If you see a trial advertised and you are interested in participating, speak to your hospital nurse or doctor.
- You may be contacted by us - if a clinical trial that is suitable for you is available, you may be contacted by our research staff either in person, if you are in the hospital or by letter or telephone if you have previously been treated here.
- You can find current clinical trials yourself on a clinical trial register.
Find a clinical trial
There are a few clinical trial registries you can use to look up clinical trials.
TrialHub is the central contact point for all clinical trials conducted at Alfred Health.
Talk to your doctor about how you can access clinical trials for your condition.
Should I participate?
After you've discussed your interest in a trial with our research staff or your hospital doctor, you need to think carefully about whether you should participate.
Remember, participating in any research is voluntary. You will receive appropriate care whether or not you choose to participate.
You should ask as many questions as you can and then carefully consider all the information before deciding to participate. You may wish to discuss the trial with your family or local doctor before making your decision.
Before you participate in a trial, ask yourself...
Participating in clinical trials has a number of possible advantages:
- gaining early access to new medications not otherwise available
- accessing clinical trial medication at no cost during the trial
- receiving close monitoring of your health
- contributing to the development of future life-saving or life-enhancing treatments
Participation in clinical trials is not without its disadvantages:
- you may experience some 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
At Alfred Health, no payments are made for participation in studies other than reimbursement for travel and expenses, if applicable.
At Alfred Health, you should not expect to bear any costs of participating in a clinical trial. Travel expenses may be reimbursed if applicable.
We do not pay participants for participation in clinical trials.
You will be given a full plain language explanation of the clinical trial, in writing and verbally. The explanation will include things such as:
- information about the trial and the testing that has already been done
- possible risks and benefits
- 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
- any alternative treatment options and any treatments that you will not be able to have whilst you are in the trial
Every trial is different. Generally, participants are divided into two groups. One group will be treated with the trial medicine or device and the other group will be treated with the current treatment. The two groups are monitored to obtain information about the progress of their condition (if applicable) and to check for any new symptoms that could be side effects. The information is then assessed to see which group has the better outcome. Doctors can then assess the benefits and the risks of the new treatment.
Trial coordinators publish information about clinical trials in central registries. You can lookup a clinical trials conducted in Australia on the ANZCTR. The trial approach is usually documented on each clinical trial page, so you can read about what will happen during the trial. It's worth noting that these clinical trial pages are produced for researchers, so you may not understand everything. Ask your GP or the clinical trial coordinator about anything you're not sure about.
You can also lookup the meaning of medical terms in a Plain English Medical Dictionary.
By the time a medication, treatment or device reaches the clinical trial stage, it has already been extensively tested for likely side effects.
However, it is not possible to uncover all side effects until it is used in humans. 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 to participants.
Participants can obtain a written plain language explanation of the results from the Principal Investigator.
Trial results are made available to doctors and may be published in medical journals and other relevant publications.
All clinical trials are conducted in accordance with the Victorian Health Record’s Act Privacy Principles.
Your personal and health information is kept confidential and you will not be able to be identified in any medical journals or publications. Your consent to share your information with any other organisation will be obtained before information is released.
You need to make sure you understand everything about the trial before agreeing to participate. If you're not sure what something means, you can ask your GP or the trial coordinators.
Here are some examples of the types of questions you could ask:
- What testing has already been done on the new medication/treatment/device?
- How many people has the new treatment been tested on to date?
- How does participation in the study differ from the standard treatment for my condition?
- 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 in the trial 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?
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