How to be part of a clinical trial

For anyone interested in being part of a clinical trial, the first step is finding out more about trials in general and what is involved in a particular clinical trial. It is a good idea to seek out information from a number of sources.

There is a wealth of information available on this and other websites about clinical trials in general, why a person may want to be part of a clinical trial, the ethics and regulation of clinical trials in Australia and how to find a trial that is relevant.

You can use the search function on the Australian Clinical Trials website to find trials that you may be suitable for, and browse the listings of clinical trials websites and links for further information.

Who to talk to

You can talk to any of the health professionals involved in your care — general practitioners (GPs), specialists, or nursing or allied health professionals. They should be able to provide general information about clinical trials and may have information on clinical trials that are relevant to you.

Support groups or consumer health organisations with an interest in a particular disease or condition that you are interested in may also have information on trials, or be able to provide contact information for other patients who have been involved in trials.

Informed consent

Everyone taking part in a clinical trial must give ‘informed consent’ or have a parent or guardian or other legally authorised person give consent.

Informed consent means that potential participants are given information about the key facts of a clinical trial before deciding whether or not to take part. Informed consent also means that participants are provided with information on new developments throughout the trial.

You cannot be entered into a trial if you don’t want to be. If you are asked to take part, you are free to say yes or no at any time. There should be no pressure on you to enter a trial. If you are under 18, a parent or guardian has to give legal consent and you have to give your permission as well.

To help you decide whether or not to be part of a trial, members of the research team will explain the details of the trial to you. The researchers will also provide a document, usually called a participant information and consent form, which includes details about the study such as its purpose, duration, required procedures, risks and potential benefits. You can ask about anything that is not clear to you or that you do not understand. You can take your time and talk it over with family and friends or your own doctor before deciding whether to take part.

You will then decide whether or not to sign the consent document. Signing the consent document means that you are agreeing to take part in the trial and have understood what that will involve. The consent document is not a contract, and you may withdraw from the trial at any time. If you do withdraw from a clinical trial, the relationship between you and your doctor will not be affected.

If there are any changes to the trial or to the protocol, you will be kept informed and you may be asked to give your consent again before proceeding with the trial.

Giving consent for another person

Sometimes, a potential participant may be unable to give their own consent for participating in a clinical trial. Such people might include:

• those who may be temporarily unable to give consent, including unconscious patients
• those with a severe cognitive impairment, an intellectual disability, or a mental illness, including elderly patients with dementia; or
• children who are not able to give consent.

In these circumstances, consent may sometimes be given by responsible family members, guardians or someone authorised by a court to act on behalf of the person who is not able to give informed consent.

In some cases, family members or guardians may also be needed to help a person make the decision about whether or not to take part in a clinical trial (even though the person will need to provide their own informed consent). This is particularly the case for people with a less severe cognitive impairment, intellectual disability or mental illness, or for those whose first language is not English.

Questions to ask

If you are thinking of being part of a clinical trial, you should know as much as possible about the trial and your involvement in it. You can discuss your questions with your doctor and with the research team. You may also find some of the answers to your questions in the participant information and consent form.

When you plan to discuss participation

• consider taking a family member or friend along for support and for help in asking questions or recording answers
• plan what to ask ahead of time, but don’t hesitate to ask any new questions that you think of while you’re there
• write down your questions in advance to make sure you remember to ask them all
• write down or record the answers, so that you can review them whenever you want
• remember that you can ask further questions to the team running the trial at any time
• remember that you can withdraw from the trial at any time and resume other treatment, if that is recommended.

Here are some questions that you may want to ask:

About the trial

• What is the aim of the trial and how will it help people?
• Has the intervention been tested before and, if so, what was the outcome?
• Will the trial use a placebo (a ‘dummy’ treatment), standard care or another established intervention as the control to compare with the new intervention?
• Who is funding the trial?

Your involvement

• How might this trial affect my daily life? How much of my time will be needed?
• What kinds of tests and experimental interventions are involved?
• Will I have to complete questionnaires or keep a diary?
• Will I need to spend time in hospital?
• Will I need to take time off work or school?
• Where will the trial be conducted and will I have to travel to be part of it?
• Will I be able to take my regular medications while participating in the trial?
• How long is the trial expected to last? How long will I have to be part of it?
• What will happen if I stop the trial intervention or leave the trial before it ends?
• Who will be in charge of my care? Who can I contact for support and information during the trial? Will someone be available 24 hours a day?

Risks

• What are the risks of taking part in this trial? What are the possible side effects of the trial intervention?
• How do the possible risks, side effects and benefits in the trial compare with my current treatment or care?
• If people receiving one intervention in the trial respond much better than people receiving the other intervention or standard care, will all participants be given access to the more effective intervention?

Costs

• Who will pay for the experimental intervention?
• Will I be paid to participate in the trial?
• Will my expenses be covered?
• If there are complications that arise from the trial, who is responsible for paying for any costs that are associated with them?

After the trial

• What follow-up care is available after the trial?
• How long will it be before the results of the trial are known?
• How do I find out the results of the trial?
• Will I have access to the experimental intervention after the trial if I wish to continue with it?

Leaving a trial

You can stop taking part in a trial at any time. You may decide to stop taking part in a trial if your condition is getting worse, you are finding it difficult to participate or you have concerns about the intervention. You can also choose to leave the trial at any time without giving a reason and without it affecting the care that you receive.

If you do withdraw from a clinical trial, the relationship between you and your doctor will not be affected; however, it is important to discuss your decision to leave a trial with the research team so that they can advise you about any other effects of leaving the trial and what will happen to information about you that has been collected for the trial.

After you leave the trial, your doctor will talk to you about other treatment for your disease or condition, if it is recommended.

If there are signs that the intervention in a trial could be unsafe, the research team or the regulators monitoring the trial will stop the trial. Also, if the new intervention is found to be clearly superior or inferior during the trial, the trial may be stopped to reduce the number of people who receive the less beneficial intervention.