A clinical trial is a scientific study of a new drug or device which involves human volunteers. Clinical trials are a test of the effectiveness of the new treatment and how safe it is. Clinical trials are also used to find new uses for existing medicines.
Why are clinical trials needed?
Clinical trials are necessary to show that a new treatment is safe and effective for use in humans. 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.
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 of doctors, nurses, researchers, lawyers, ministers of religion and male and female members of the public.
Who instigates clinical trials?
Clinical trials may be instigated by drug or device companies who have developed a new treatment. They are called the “Sponsor” of the clinical trial and must be an Australian business entity. Sometimes the drug/device has been developed by an overseas company. In such 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 instigated by medical research organisations and individual or groups of health care practitioners 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 care professionals. The clinical trial team is responsible for conduct of the whole trial.
How are trials conducted?
There are a number of different types of clinical trials. Generally participants are divided into two groups. One group will be treated the trial medicine/device ( treatment group) and the other group will be treated with the current treatment (control group). The two groups are monitored to obtain information about the progress of their illness 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.
What are the benefits from participation in a clinical trial?
There are a number of possible advantages of participating in clinical trials. These may include:
- 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 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.
Participants are not paid to be part of a study
At The Royal Melbourne Hospital, no payments are made for participation in studies other than reimbursement for travel and expenses if applicable.
How can a person participate in a clinical trial?
Sometimes clinical trials are advertised within the hospital and in the media. If you are interested in participating in a clinical trial speak to your hospital doctor.
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.
Before making this important decision you will be given a full plain-language explanation of the clinical trial, in writing and verbally. You should ask any questions that you wish to and 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. Remember, participating in any research is voluntary. You will receive appropriate care for your illness whether or not you choose to participate.
The explanation of the study will include things such as the:
- 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;
- any alternative treatment options and any treatments that you will not be able to have whilst you are in the trial.
What happens if side effects occur from taking a drug in a clinical trial?
By the time a drug reaches the clinical trial it has already been extensively tested for likely side effects. However it is not possible to know 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.
What happens with the results from clinical trials?
Once available the results are made available to doctors and may be published in medical journals and other relevant publications. Participants can obtain a written plain language explanation of the results from the Principal Investigator.
What about my privacy?
All clinical trials are conducted in accordance with the Victorian Health Record’s Act Privacy Principles. Therefore 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.
What else should I know?
We encourage you to ask for an explanation about any information that you do not understand.
Here are some questions you may like to ask when considering participating in a clinical trial:
- 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?