Key questions about clinical trials

Answers to commonly asked questions about clinical trials.

Are cancer treatment clinical trials safe?

Cancer clinical trials are the best way to test new treatments or see whether a particular treatment works better. In Australia, all clinical trials have to be approved by a human research ethics committee before they can begin. This assures participants that their rights and any research benefits and risks have been carefully considered. Every trial is bound by law to follow a set of strict rules or guidelines, to ensure participant’s safety.

Who can participate in a cancer clinical trial?

All cancer clinical trials have rules that determine who can participate – these are called eligibility criteria. For more information see our page on clinical trial eligibility.

What are the different phases of cancer clinical trials?

For more information, see our resource here for the different phases of clinical trials.

What are the different types of cancer clinical trials?

For more information, see our resource here for the different types of clinical trials.

How can I participate in a cancer clinical trial?

All cancer clinical trials are different and each has specific criteria for people to take part. The best way to find out if a cancer clinical trial might be right for you is to ask your doctor. They can then discuss it with you further.

Is it free to go on a cancer clinical trial?

Generally, the costs of participating in a clinical trial will be paid for by the organisation that is funding or conducting the research. For some clinical trials, this will include treatment, tests and patient check-ups. Travel or out-of-pocket costs may be refunded depending on who sponsors the trial. Ask your doctor if this is available. People who are not Australian permanent residents or citizens will have to cover costs.

Will I be paid to participate in a cancer clinical trial?

People participating in cancer clinical trials do not usually receive payment. In some circumstances, you may be paid back for certain out-of-pocket expenses eg. travel, and parking. You should confirm this information with the trial coordinator before you participate.

How long do cancer clinical trials go for?

There are many factors that determine how long a cancer clinical trial goes for. What is being tested and the phase of the trial are two things that can impact how long a cancer clinical trial goes for. From start to finish, a study can often take years or even decades. However, you may only need to be involved for some of this time. It may be a one-off couple of hours, or you may need to do something every few weeks, months, or years.

Can I be involved in more than one cancer clinical trial?

You may be interested in joining multiple studies. Check with the clinical trial coordinator whether you can participate in more than one study at the same time. If you can, think about whether you’ll be able to commit to the different requirements of each study, including the additional time involved.

Can I have other treatment if I go on a clinical trial?

This is different for every trial. Check with the clinical trial coordinator whether the trial you are participating in will have an impact on any other treatment that you are having or planning to have. This includes medicines for the symptoms or side effects associated with your cancer, as well as any complementary therapies such as herbal supplements or massage therapy. Ask your doctor if you need to stop or delay these other treatments, or whether they need to be modified (for example, changing the dose).

Can people living in regional and rural Victoria access clinical trials?

Clinical trials are available at hospitals throughout Victoria, including in rural or regional areas. Ask your doctor about the clinical trials available near you, or search for a clinical trial using the Victorian Cancer Trials Link website.

If you are unable to access a clinical trial that is close to home, speak to your doctor about travel and accommodation options. Some clinical trials are sponsored by pharmaceutical companies and may provide reimbursements for expenses associated with travel and accommodation.

Will I get better cancer treatment if I am on a clinical trial?

There are many advantages of being involved in a cancer clinical trial. Depending on the study, you may be able to:

  • Access programs, medicines or other treatments that are not available outside of the study and may be better than the current standard care for your cancer.
  • Access expensive drugs that are not currently covered by the Pharmaceutical Benefits Scheme.
  • See your treatment team, including specialists, more often.
  • Be motivated to take an active part in your health care
  • Know you’ve made a valuable contribution to helping others in the future.

It is important to know that joining a study doesn’t always mean you will be better off than before or compared to other people in a similar situation. This is because although researchers may predict that the outcomes of their study will be positive, not everyone will respond in the way that they hope.

In a clinical trial, you may be in the control arm and not given the experimental treatment. If this is the case, you will receive the best standard care available and be monitored more frequently and closely than usual. Either way, your doctor and the clinical trials or research nurse will discuss the possible advantages for you before you join a study.

Does everyone on a clinical trial get the same treatment or medication?

Accuracy and reliability of research are essential. Researchers need to know that the results of a study are accurate and not caused by chance or bias.
To make sure a cancer clinical trial is fair and reliable, many cancer clinical trials are Randomised Controlled Trials (RCTs).

A Randomised Controlled Trial means that participants in the clinical trial are split into two or more groups, these are known as treatment arms. Each group receives different treatments. The results of each group are then compared. Selection into each group is random and researchers can not choose who goes into each group.

Most phase 3 trials and some phase 2 trials are randomised.

  • Test or experimental arm –this group is given the new treatment that is being tested. Sometimes, the experimental treatment is given in addition to the current standard treatment.
  • Control arm –this group receives the current standard treatment for the disease or, if current standard treatment is not available, an inactive treatment known as a placebo.

When randomly allocated groups are compared with each other, it is possible to work out which treatment is better. This is because researchers can be certain that the results are related to the treatment, and not to any other factors.

Learn more about randomisation in this video

What is informed consent?

Before becoming part of a clinical trial, all participants have to give 'informed consent'. This means you will be asked to confirm you have read and understood the purpose, risks and possible outcomes of the research before deciding to join.

Informed consent involves:

  • Written information – after talking to you about the study, members of the research team will give you a written document known as the participant information. This explains the purpose of the study, what is expected of you if you join, what the possible risks are, how your information will be used, and how the results will be presented.
  • Informed consent discussion – after you have read the participant information, you can discuss the study in more detail with the clinical trials or research team and ask them to explain anything you find unclear.
  • Agreement in writing – once all your questions have been answered, you can then decide whether or not to join the study. If you do choose to take part, you will be asked to sign the informed consent form. This confirms that you understand the purpose of the study, what is involved, and you agree to participate.

For some low-risk studies, written informed consent may not be needed. For people under 18, a parent or guardian has to give legal consent as well.

Signing the form is not a contract and you can change your mind at any time. If the study changes or new information becomes available while you are involved, you will be given updated participant information. You will need to sign an updated version of the consent form if you are willing to continue. Sometimes you may need to consent to each aspect of a study.

What is included in ‘participant information’?

Researchers must provide written information about the research study to anyone thinking about joining. This is called participant (or patient) information. It answers a range of questions about the study, including:

  • the purpose of the study
  • if it is a clinical trial, and what phase it is in
  • who can participate in the study
  • who is running the study (institution and researchers)
  • who has approved the research
  • who is funding the study
  • how the study will be run and what you need to do
  • how the study will be monitored
  • whether you will need to have tests, scans or other procedures
  • how long you need to be involved
  • where you need to go for appointments, treatments or meetings
  • whether the researchers need to see your medical records
  • whether you will be paid back (reimbursed) for any expenses related to the study (e.g. transport or parking costs)
  • information about possible side effects or other risks
  • information about possible benefits
  • any restrictions on things you can do while you are on the study (e.g. treatments you can’t have)
  • who to contact for more information or if you have any problems or complaints during the study
  • information about your rights, such as keeping your records private and your ability to withdraw from a study.

Am I able to withdraw from a clinical trial?

Participating in research is voluntary and you can stop (withdraw) at any time. You may want to leave because you no longer have the time or energy for it, don’t feel it is helping, have side effects or your health is worsening, move away from the treatment centre, or change your mind.

If you decide to withdraw from a clinical trial, you will receive the standard treatment currently the best option for you. You may be asked why you are withdrawing from the trial – you do not have to give a reason, but it can help the research team understand more about the needs of participants if you do.

You may also be asked if the team can still collect some information about your health. This can help them learn more, but it is your choice.

What about my data privacy?

Medical records are private and confidential, including those about your involvement in a clinical trial. Health professionals directly involved in y our care or study can access your personal and medical information, but only if it’s necessary for their work. They can’t give any information about you to others unless it is relevant to your health care or the study.

Clinical trials and other research studies collect personal data about you. The participant information may mention who will and won’t have access to your personal data. You might be asked to consent to the research team seeing your existing medical records or particular test results.

Information collected during the study is often de-identified. In most cases, this means that your name will be removed and replaced with a unique participant number so your identity cannot be revealed unless necessary, e.g. for safety reasons. Being de-identified means when the results are published in medical journal articles or discussed at medical conferences, you will not be named.

At the end of a clinical trial, all personal information is stored in a secure place for at least 15 years before it can be destroyed. This is a legal requirement. If you have questions or concerns about your privacy in a clinical trial or other research study, talk to the clinical trials or research nurse.

Will I be notified about the results of my trial?

It can take a while to get trial results. Usually, results are available 2–5 years after the study finishes, but sometimes it can take 10 years or more. The results of most clinical trials will be published in medical journals and presented at medical conferences and scientific meetings.

If you’d like to know the results of the study you participated in, start by asking your doctor or clinical trials coordinator. The participant information you read at the beginning of the trial and the informed consent document you signed often say how and when the results will be available.

The results are usually reported for everyone in the trial together, so you may not be able to see your individual results. You may want to talk to your doctor about what the overall results mean. Sometimes the study results are shared with participants in an easy-to-understand document (lay summary).

Why are clinical trials important?

Clinical trials are the best way to demonstrate whether a new approach to prevention, screening, diagnosis or treatment works better than the current method and is safe. If the new approach is shown to work better than the existing methods, then it may become the new standard way of doing things.

This is why clinical trials are important – testing new interventions through clinical trials leads to cancer breakthroughs.

Do all clinical trials have placebos?

Every clinical trial is different and will have a different structure depending on what they are testing and who they are testing it on. Because of this, not every clinical trial involves a placebo. In cancer treatment trials, placebo interventions will always be given in addition to standard of care treatment. You should speak to your doctor about whether a particular clinical trial involves a placebo.

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.


Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.