Patients and carers
What are cancer clinical trials?
Cancer clinical trials can focus on ways to:
In NSW, cancer clinical trials are available at many hospitals and cancer services and many people with cancer have the chance to take part in a clinical trial.
Key things to know about cancer clinical trials:
- There are clinical trials suitable for people of all ages with different types and stages of cancer.
- Your cancer specialist may ask whether you want to take part in a clinical trial.
- You will be informed about what is involved in the clinical trial and how it is different from the usual treatment you would receive.
- You can talk to your doctors, other healthcare professionals, and your family and friends to help you determine if you want to participate in the clinical trial.
- Even if you start a cancer clinical trial, you can always leave if you change your mind.
The purpose of clinical trials is to find out if a new treatment or care option:
Is safe to use
Has any side effects
Works better than a standard treatment
Makes you feel better
It’s important that anyone participating in a clinical trial knows that their safety is the highest priority.
- Any new treatments used in a clinical trial will have undergone significant testing before becoming available to patients
- Usually in a clinical trial, the patient will receive either the current best treatment available or a new treatment.
- Some clinical trials use a placebo (a treatment with no active medicine). You will still receive appropriate medical care during the trial
Any individual has the choice to enter or leave a clinical trial. No one will be forced to take part in a clinical trial.
Importance of clinical trials
Medical breakthroughs result from the work of many people who devote time and energy towards improving treatment and care options for those affected by cancer. These people include doctors, healthcare professionals and patients. Without clinical trials, researchers would not be able to improve cancer treatments or find better ways to care for people with cancer or other health conditions.
Participation in clinical trials benefits both patients and the community. Depending on a patient’s diagnosis, a doctor may offer one or more clinical trials for consideration.
Deciding to take part in a clinical trial
Deciding on treatment and whether to take part in a cancer clinical trial can feel difficult. Your cancer care team can support you as you make this decision, and you may wish to talk with your family, carers or friends about what feels right for you.
The Cancer Institute NSW provides resources to support decision‑making. These resources can be used in discussions with specialist teams or general practitioners. Taking part in a clinical trial is voluntary. You can choose not to take part, or to leave a trial at any time, without affecting your ongoing care.
‘I have cancer… Is a clinical trial an option for me?’ This resource explains the basics of clinical trials, including a glossary of terms. It is available in 20 languages and can be read on-screen, printed or listened to.
Questions you may find helpful to ask your doctor
You may not need to ask all of these questions. Choose the ones that feel most relevant to you and your situation.
- What is the clinical trial studying and how is it different from the usual treatment or care for my cancer?
- Does the clinical trial treatment aim to treat or control my cancer?
- What are the potential benefits and risks of the proposed treatment?
- Has this treatment been used before?
- How long will I be in the clinical trial?
- Am I eligible for travel or other assistance?
- Will my healthcare insurance change?
- How will my privacy be protected?
- Can I still have other treatments or herbal medicines?
- If I join this study, will I miss out on other treatment opportunities?
- Where is the clinical trial taking place?
- Will the clinical trial affect the cost of my treatment?
- Who is the main doctor looking after me while I am on the clinical trial?
- Who will be my main contact for support?
- How will my General Practitioner or other healthcare professional be involved?
Steps to take part in a clinical trial
1. Find a trial
Your doctor might suggest a clinical trial.
You can also search for clinical trials.
2. Eligibility
Most clinical trials specify the characteristics a person must have to join the clinical trial. Your doctor will check if you meet the criteria to join.
3. Read and decide
Read the Participant Information Sheet and Consent Form (PICF). If you agree to join, you will be asked to sign the PICF.
4. During the trial
Follow instructions you are given about the clinical trial and talk to the clinical trial team about any symptoms you may experience.
5. After the trial
The clinical trial team may stay in contact with you for follow up.
Steps to take part in a clinical trial
The treating doctor or the GP might suggest a clinical trial as an option. Family, friends or carers can also help find available clinical trials online.
It is important to learn about clinical trials from different sources. Look at general information and also specific clinical trials.
Determining if a clinical trial is suitable for a person will depend on many factors, including the questions the clinical trial is trying to answer. Most clinical trials have specific characteristics required for participation, for example, the type of cancer, age and how well the person is currently feeling.
The clinical trial team will ask questions and request tests to check if a person can join the clinical trial.
These guidelines are called eligibility criteria and it is specific for each clinical trial. To become an eligible clinical trial 'participant', a person must meet all inclusion criteria and have none of the characteristics listed in the exclusion criteria.
During the eligibility review, the clinical trial doctor and the clinical trial team will obtain the participant's medical history and may ask for additional tests.
People who volunteer to join a clinical trial will be asked to sign a Participant Information Sheet and Consent Form (PICF). This document explains in plain language all aspects of clinical trial participation, tests performed, visit schedule and duration of the clinical trial. It also contains the contact details of the clinical trial team, in case the participant needs to contact them.
The PICF ensures volunteers understand their involvement a clinical trial, but it is not a legal contract. A person can withdraw from a clinical trial at any time and still receive the best available treatment
Discussion with a treating doctor or health care team is encouraged. It is also recommended that family or carers be involved in the decision to enrol in a clinical trial or not.
The clinical trial team may still want to check on participants' wellbeing from time to time, either by phone or asking participants to visit the hospital. These follow up visits are important to collect additional information about the research and the participant's health.
Considerations for taking part in a clinical trial
The decision to join a clinical trial is personal. You should not feel pressured to take part and should feel comfortable asking the research team questions about the trial treatment, tests and any associated costs.
Taking part in a clinical trial may affect your wellbeing, as well as others affected by the same or a similar medical condition.
Benefits
Risks
How do clinical trials progress?
Research, including preclinical (laboratory) and clinical trials involve a series of stages, called phases.
Each phase is designed to answer a separate research question about the new treatment.
Early discovery and ongoing preclinical research
Phase 1
Safety and best dosage levels are determined
1-2 dozen participants
Phase 2
Response to new treatment is recorded and analysed
Under 100 participants
Phase 3
Results studied and submitted to regulatory agency for approval
More than 100 participants
Phase 4
Treatment is marketed
Over 1000 involved
If a new treatment or intervention is successful in one phase, the research may proceed to further testing in the next phase.
Participants may be able to join a trial at different phases, depending on the research question and whether the trial is right for them.
Preclinical
Preclinical research is an early stage where a drug, procedure or other medical treatment is tested, usually in laboratory animals, before it is tested in humans.
Phase 1
Phase one clinical trials are the first time a new treatment is tested in humans. In this phase, only a small group of people will be involved. The goal of a phase one trial is to check treatment safety, and what dosage range is most appropriate and safe.
Phase 2
Phase two clinical trials include a larger group of people. In this phase researchers aim to check the benefits and effects of the treatment, ongoing safety, and how it is best used.
Phase 3
Phase three is the final stage before the treatment can be approved and used by the public. The study progresses to recruit an even larger group of people representing the general population.
Phase three studies confirm efficacy and monitor long-term safety. By collecting information from a large population, it gives more confidence to the data.
After Phase 3 clinical trials are completed successfully, the treatment may be approved for use in the general population by regulatory bodies (e.g. Australia’s Therapeutic Goods Administration TGA).
Phase 4
Phase four occurs after a regulatory body, such as Australia’s Therapeutic Goods Administration (TGA) approves the treatment because it is confirmed safe and effective for the general population. Phase four studies often focus on the long-term safety and effectiveness of the treatment in the general population while it is on the market.
Safety during a clinical trial
Clinical trials are carefully designed by scientists and doctors and must be approved by an ethics committee before they can begin recruiting volunteers. The approval ensures that the research is conducted in a way that protects the rights and welfare of participants. For more information about how safety is ensured during clinical trials, please visit Cancer Australia | Understanding Clinical Trials