About clinical trials

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.

Each clinical medication 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.

There are different types of clinical trials. Generally, participants are divided into two groups:

• One group will be treated with the trial medicine or device (treatment group)
• The other group will be treated with the current treatment or a placebo (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.

There are several 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
• 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 or stay in hospital longer so your condition can be monitored.

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.

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. They may contact you in person if you are in the hospital, or by letter or phone 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 have 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 you choose to participate or not.

The explanation of the study will include things such as:

• Information about the trial medication or 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 while you are in the trial

By the time a medication 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.

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.

All clinical trials are conducted in accordance with the Victorian Health Records Act Privacy Principles. Your information is 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 is obtained before information is released.