Have you ever seen the words ‘clinical trial’ and wondered what they actually mean?

If you or someone you love has been diagnosed with cancer, you may also wonder whether taking part in a clinical trial is safe, what treatment you might receive and whether it could be right for you.

Here’s what you need to know.

What is a clinical trial?

Clinical trials are carefully designed research studies that help doctors and researchers find better ways to prevent, diagnose, treat or manage diseases such as cancer. Every trial has a specific research question it is trying to answer. For example, researchers might want to know whether a new treatment works better than the current standard treatment, whether combining two treatments provides greater benefit, or whether a new test can help doctors identify which treatment is most suitable for a particular person. Clinical trials are an important part of improving cancer care. Many of the treatments doctors use today were once tested in clinical trials.

Are clinical trials safe?

Yes. Safety is a fundamental part of every clinical trial. Before a trial can begin, it must undergo rigorous scientific and ethical review. In Australia, clinical trials are reviewed by an independent Human Research Ethics Committee (HREC), which considers whether the research is scientifically sound, whether the potential benefits justify the risks and whether participants’ rights, safety and wellbeing are protected. Trials also have strict protocols that set out who can participate, what treatment is given, what tests are required and how participants will be monitored. Once a trial is underway, participants are closely monitored for side effects and other changes in their health. Researchers continually collect and review safety information throughout the study. Importantly, taking part in a clinical trial is voluntary. You should be given information about the trial, including its potential benefits and risks, so you can make an informed decision about whether you want to participate.

Could I receive better treatment than the current standard of care?

Sometimes, yes. Clinical trials are often designed because researchers believe there is an opportunity to improve on current treatment. Depending on the trial, the treatment being studied may be a new drug, a new combination of existing treatments, a different way of delivering treatment or another approach that researchers hope will provide better outcomes. In some trials, participants receive the new treatment being studied and others receive the current standard treatment. This comparison allows researchers to determine whether the new approach provides additional benefit. Importantly, the standard treatment used in a clinical trial is generally the best treatment currently available for that particular situation. A clinical trial should never mean receiving treatment that researchers already know is inferior. Some trials may also compare different established treatments or treatment strategies. Whether you receive the new treatment, standard treatment or another approach depends on the design of the individual trial.

What if I don’t want to participate?

That’s completely okay. Taking part in a clinical trial is your choice. You can ask as many questions as you need before deciding and choosing not to participate will not affect your usual medical care. If you do agree to participate, you will provide informed consent. This means you should understand what the trial involves, including the potential benefits, risks, tests and commitments involved, before agreeing to take part. You can also generally choose to leave a trial at any time.

What are the different types of clinical trials?

Clinical trials can investigate many different aspects of cancer care, including:

• Treatment trials that test new treatments, new combinations or new ways of delivering existing treatments.
• Diagnostic trials  investigate new tests or methods to diagnose cancer.
• Screening trials explore better ways to detect cancer earlier.
• Surgical and medical device trials evaluate new or improved procedures, surgical techniques or medical devices.
• Quality-of-life trials investigate ways to improve comfort, wellbeing and daily life during or after cancer treatment.
• Prevention trials explore ways to reduce the risk of developing a disease.

 

What happens if I join a clinical trial?

Before you decide, your doctor or research team will explain what the trial involves and check whether you are eligible. If you participate, you will have a clear plan outlining your treatment, appointments, tests and monitoring. The research team will explain what is expected of you and who you can contact if you have questions or concerns. The experience is different for every trial. Some require more appointments or tests than standard care, while others may fit relatively easily into your existing treatment schedule.

What questions should I ask?

If you are considering a clinical trial, don’t be afraid to ask questions.

You could ask:

• Why is this trial being offered to me?
• What is the trial trying to find out?
• What treatment or care might I receive?
• What are the potential benefits and risks?
• How does the trial treatment compare with standard treatment?
• What tests and appointments will I need?
• What happens if the treatment doesn’t work or I experience side effects?
• Can I leave the trial if I change my mind?
• Will taking part affect my usual care?

Your doctor or the clinical trial team should be able to answer these questions and give you the information you need to make a decision.

Why are clinical trials important?

Clinical trials are how we find out whether new approaches to cancer care are actually better, safer or more effective than what we currently have. For people who participate, a trial may provide access to a new treatment or approach that isn’t yet routinely available. Just as importantly, participants help generate evidence that can improve treatment for people diagnosed with cancer in the future. Every clinical trial has a purpose. Every participant contributes to what we learn. And the evidence generated through clinical trials helps move cancer care forward. If you would like to learn more about clinical trials, including what to consider before taking part, visit the Australian Clinical Trials Alliance Consumer Involvement Toolkit. You can also visit ANZUP’s Clinical Trials Overview to learn more about clinical trials and what questions you may want to ask your doctor.