How trials are run


Can I bring a relative or friend to the ‘informed consent’ meeting?
Yes, your treating specialist will encourage you to do so. Having a friend or relative with you will help you discuss all aspects of the trial and will help you make an informed decision about whether participating in the trial is the best thing for you to do. If a friend or relative cannot come to the meeting with you, you will be provided with information sheets about the trial and you will be able to discuss them with your to family and friends.

Can I tape the meeting or take notes?

You will need to discuss this with your doctor and obtain his/her permission to do so.

Who will be allowed to see my medical records?

The National Health and Medical Research Council (NHMRC) sets out guidelines regarding the ethical conduct of clinical trials. As such, all medical records are confidential with only authorised medical staff involved in the trial and analysing trial results able to access your medical records. All patients will remain anonymous with only group results ever being published.

What information about me will be on the computer?

Your medical information or data gathered from the trial in your patient file will be entered into a computer, which will be security protected. The NHMRC clinical trial guidelines are adhered to with medical information being stored in locked cabinets in secure rooms, and all computer access is password protected.

Who will be told I am in a trial?

The medical staff involved in conducting the trial will be the only people who will be told that you are participating in the trial. If you would like to tell your family and friends that you are participating in a clinical trial, then it is up to you to tell them.

What will I do if I take part? Will I have to spend more time in hospital or having tests?

When you agree to take part in a clinical trial you will be provided with an information booklet which will outline all aspects of the trial. This is to ensure that everyone is fully informed about the trial. You will need to observe the conditions of the trial you are participating in. Depending on the trial, you may have to spend more time in hospital or have more tests.

What about my expenses, such as travelling costs?

All expenses incurred in participating in the trial are usually covered. The trial information will provide you with more information.

Am I covered by insurance if things go wrong?

All clinical trials have an insurance provision, which means that you will be covered should anything go wrong. The information provided to you about the trial will provide you with more detailed information.