Safety of Trials

What treatment will I get if I decide not to enter the trial?

If you decide that you do not wish to participate in a clinical trial, you will still receive the same treatment and care from your GP and treating specialist as you would normally do.

Can I leave the trial if I want to?

If you decide that you do not wish to be part of the clinical trial anymore, you are able to withdraw from the trial at any time.

Who can I contact in an emergency?

You will be given a list of contact numbers in the trial information booklet when you begin the trial.

Is there anything I am not allowed to do while I am in the trial?

You will need to discuss this with the clinical trial medical team, as this will depend on the trial that you are participating in.

What will happen if I get side effects? 

At the beginning of the trial you will be given contact details for the medical staff involved in the trial. Should you experience any side effects while participating in a trial you must talk to the medical staff where the trial is being conducted. The medical staff is there to help and assist you and you need to discuss any problems you may be experiencing.

Your side effects may be able to be treated, however if you are experiencing severe side effects you may need to withdraw from the trial.

Who makes sure the trial is safe and properly run?

All clinical trials must be conducted in accordance with stringent guidelines. The National Health and Medical Research Council (NHMRC) is Australia’s leading expert body promoting the development and maintenance of public and individual health standards. The NHMRC sets out guidelines which must be adhered to.

An ethics committee must approve all trials involving patients before permission is granted to run the trial. All trials have oversight committees coding the data. The institution conducting the trial ensures that the trial is safe, properly designed, managed and monitored; and is approved by the institution’s ethics committee. Researchers are required to provide periodic reports on the outcomes of the trial.

The safety and management of the clinical trial will be detailed in the trial information that you will be provided with when you consent to participating in the trial.

Are there any drugs or medicines I shouldn’t take while I am in the trial?

This will be specified in the trial information you are provided before you begin the trial.