If you or someone you love has cancer, the idea of taking part in a clinical trial can bring up a lot of questions. It’s a daunting prospect and hard to navigate.  Is it safe? Will the treatment work? Could it be better than the treatment I’m already receiving? And how do I know the people running the trial have my best interests at heart?

These are all fair questions and you need to ask them. When it comes to your health, you want to know that you can trust the people looking after you and the research they recommend.

Clinical trials are an important part of improving cancer treatment. They help researchers find out whether new treatments or different approaches to existing treatments can lead to better outcomes. But just as importantly, trials must be conducted responsibly, with safeguards in place to protect the people who take part.

So, what does that mean for you?

So how are clinical trials kept safe?

Clinical trials in Australia must follow ethical guidelines, regulatory requirements and internationally recognised standards designed to protect participants and support reliable research.

Before a trial begins, an independent Human Research Ethics Committee (HREC) reviews the study, including its potential benefits and risks and how participants’ rights, safety and wellbeing will be protected. Trials involving unapproved medicines or other therapeutic goods must also meet the relevant requirements of the Therapeutic Goods Administration (TGA). Researchers follow Good Clinical Practice, an international standard for conducting research responsibly.

Safety is monitored throughout a trial, with procedures for identifying, reporting and responding to side effects and other concerns. Participants are also given clear information about what the study involves, including its potential benefits, risks and requirements.

These safeguards are so important, but they can’t guarantee that a treatment will work or that unexpected side effects won’t occur. What they do is help ensure the research is reviewed carefully and conducted ethically, with participants’ safety and wellbeing at the forefront.

Could I receive better treatment in a clinical trial?

Possibly. Clinical trials are often developed because researchers believe there may be a better way to treat a particular cancer. This could mean testing a new medicine, combining existing treatments in a different way, or exploring a different approach to treatment.

To find out whether an approach works better, researchers need to compare its results with an appropriate alternative. Depending on the trial, some participants may receive the treatment being studied, while others receive the current standard treatment or another comparison approach.

The standard treatment is an established treatment considered appropriate for that particular situation and every situation is different. The exact options depend on the cancer, the stage of the disease and the trial’s design.

It’s important to understand that taking part in a clinical trial doesn’t guarantee you’ll receive a new treatment or that you’ll benefit personally. The purpose is to find out whether a treatment or approach is safe and effective, and whether it could improve care for people with cancer.

What is informed consent?

Trust also means knowing what you’re agreeing to. Before joining a clinical trial, you’ll be given information about the study and have the opportunity to ask questions. This is known as informed consent.

You should be able to understand why the trial is being conducted, what treatment is involved, the potential benefits and risks, what taking part will require and what other treatment options are available.

And there’s absolutely no need to rush your decision. Take the time you need, talk it through with your treating doctor or loved ones, and ask for anything that isn’t clear to be explained in plain language. And if you feel you need a translator, always ask so that they can help explain the information. Always ask the question: What does this mean for me and what is the impact on my every day?

Remember taking part in a clinical trial is voluntary. You can choose not to participate, and you can withdraw if you change your mind. Your decision should not affect your access to appropriate medical care.

Who can I talk to if I have concerns?

You don’t have to work everything out on your own. Your treating doctor and the clinical trial team can help you understand the study, explain what participation would mean for your circumstances and discuss your options.

It can help to have a few questions ready, such as:

• What is the trial trying to find out?
• What do researchers already know about the treatment?
• What are the possible benefits and risks for me?
• What treatment would I receive if I didn’t take part?
• Will I need extra appointments, tests or procedures?
• Who should I contact if I experience side effects or have concerns?

If you’re unsure about anything, speak up. There are no silly questions when it comes to your health, and you should feel comfortable asking for more information before making a decision.

Building trust through research

Trust isn’t built on promises of a breakthrough. It’s built through transparency, independent oversight, honest conversations and respect for the people who take part.

At ANZUP, clinical trials bring together clinicians, researchers and other experts to investigate ways to improve outcomes for people affected by bladder, kidney, testicular, penile and prostate cancers.

The people who volunteer to participate in these trials play an important role in advancing cancer research. Their participation helps researchers understand which treatments work, which approaches may be less effective and how care can be improved in the future.

So, can you trust a clinical trial? Clinical trials are subject to safeguards designed to protect participants and ensure research is conducted responsibly. But every trial is different, and it’s important to understand what a particular study involves before deciding whether it’s right for you.

You deserve clear information, honest answers and the time and support to make an informed choice.