Before taking part in a Clinical Trial
Joining a clinical trial is a big decision, and it is important to know what to expect and make sure you have all the information you need. Here’s what you should understand before deciding if it is the right choice for you.
This section contains information on the following:
Before you join a Clinical Trial
Understanding eligibility criteria
The information you should get about the trial
Giving your permission (informed consent)
What you should know about side effects
If you decide to leave the trial
Before taking part in a clinical trial, summarised
Before you join a Clinical Trial
Before you decide to join a clinical trial, the research team must clearly explain what the trial is about. This includes:
the purpose of the trial
how long the trial will go for
what treatments or methods will be tested
possible risks and side effects
benefits the trial could offer
what tests, procedures and check-ups you may have
how often follow-up appointments are needed
any costs involved, like the costs of attending appointments’
whether samples (like blood or tissue) will be kept for future research
who you can contact during the trial if you have any concerns.
It’s important to also know where your treatment will take place and whether you might need to stay in the hospital.
For more information about joining a clinical trial, head to our page here.
Understanding eligibility criteria
Every clinical trial has rules about who can participate. These rules, called ‘eligibility criteria’, depend on the specific trial.
Each trial has its own set of criteria, which can sometimes be very detailed and complicated. It can be overwhelming to read through eligibility criteria for a trial. You may hope to get onto a trial and then you find out you are not eligible. This can cause a lot of stress and disappointment.
Learn more about the emotional impacts of taking part in a trial here.
Your specialist treatment team, which can include doctors, nurses and/or trial coordinators, are the best people to help you understand if you meet the criteria and if the trial is right for you.
The most common things that may be considered include:
your age and gender
your current physical and mental health
your cancer type and stage
how long you have had cancer
your symptoms or side effects
what treatments you have already had
how much ‘measurable disease’ you have.
Why ‘measurable disease’ matters
Sometimes, a clinical trial will only accept trial participants whose cancer has reached a certain stage or size. This is often called ‘measurable disease’. This means your cancer must be clearly seen and measured on a scan. If your cancer is stable or hasn’t progressed to a certain stage, you might not be eligible for a specific trial right now.
This may feel upsetting and confronting, especially if you had hopes of going on the trial. It can be confusing to hear that you need to wait until your cancer advances further to join a trial.
You are not being turned away because you don’t need treatment – it is just that this particular trial is studying how the treatment works in more advanced disease than your current disease.
You can ask your doctor about other options that are available for you now and to let you know when you might become eligible for future trials.
Other eligibility criteria include:
Some allergies may prevent you from joining a trial.
Some trials may require you have genetic testing, which may impact you and your family.
Your past and present mental health may impact your ability to join a trial.
Some past treatments and how long ago you had them can exclude you from joining a clinical trial.
You may be asked to use contraception during a trial. If you are not willing to do this, it may exclude you from a trial.
Ask your doctor about trials that are available for you now and in the future.
If you find a trial that interests you, your specialist treatment team can help you understand your eligibility.
The information you should get about the trial
The full details of a clinical trial should be given to you in a patient information leaflet or statement. This will include everything you need to know about the trial, like its purpose, procedures, risks and potential benefits.
The research team will go over this with you and give you time to ask questions and think things over.
Giving your permission (informed consent)
Before you join a trial, you must give informed consent, which means you agree to take part after understanding everything involved. This will involve signing a consent form. You should have the chance to ask as many questions as you need. You can also bring a trusted person with you for support. Remember, joining a clinical trial is completely voluntary, and you can decide not to take part if you’re not comfortable doing so.
Informed consent isn’t just a one-time thing; you can continue to ask questions throughout the trial.
What you understand and consent to in a clinical trial
Everyone taking part in a trial must be told about what the trial will involve, including what treatment it is, how long the trial will run, and what other tests and procedures you might need to have.
Trial participants need to understand the main purpose of the trial – is it testing a new treatment, improving an existing standard treatment or just collecting data?
All potential risks (side effects, complications) and benefits (better outcomes/prognosis) of joining the trial must be clearly explained to all participants.
Joining a trial is completely your choice (voluntary), and you can leave the trial at any time without any consequences or loss of support and care by your usual healthcare team.
Participants should be informed about any other standard treatment options outside of the clinical trial.
Participants need to feel confident that their personal health information and data will be kept private and secure during and after the trial.
Any costs associated with participation should be explained. In Australia, you should not have to pay to take part in a trial, however there may be transport or accommodation costs if you need to travel to the trial centre. You should discuss whether these costs are covered by the trial before you agree to take part
Participants should feel free to ask any questions and get answers about anything to do with the trial before deciding to join.
Participants need to provide informed consent to join the trial confirming they understand the details of the trial and agree to take part. This will require signing a document.
All these points mean that you are well informed and feel comfortable to make the best decision for your individual situation before joining any clinical trial.
For more information about joining a clinical trial, head to our page here.
What you should know about side effects
If the trial is testing a new treatment, the researchers may not know all the possible side effects. They should tell you about the risks they do know, and you can ask about any concerns you might have.
Make sure you understand any possible side effects before joining. Some side effects may require you to use medication to manage them. These medications are not always paid for by the clinical trial, so please discuss this with your treating team.
Learn more about the physical impacts of taking part in a trial here.
If you decide to leave a trial
You can leave a clinical trial at any time, for any reason, without it affecting your ongoing care. If you choose to withdraw, you will continue to receive standard treatment for your cancer. The research team will explain what will happen to any data they’ve already collected from you.
Before taking part in a trial, summarised
Before you join a trial: The research team will explain the trial’s purpose, risks, benefits, tests and where treatment will happen.
Eligibility: Trials have specific rules about who can join based on things like age, cancer type and stage.
Patient information: You will get a leaflet/booklet with all the trial details, and you can ask questions before deciding to join.
Informed consent: You need to sign an agreement to join the clinical trial, and you can ask questions at any time.
Side effects: The research team will let you know about any known side effects, but some may not be fully understood yet.
Leaving the trial: You can withdraw from a clinical trial at any time without affecting your care.
Taking part in a clinical trial is a personal decision. Make sure you have all the information, feel comfortable asking questions, and talk with your doctor before deciding whether it’s the right option for you.
