Why be part of a clinical trial?

New interventions that help people to live longer, have less pain or be free of disability are only possible because of the willingness of people to participate in clinical trials. Both healthy participants and those diagnosed with a disease or condition are needed to help find new ways to diagnose, prevent, treat or cure disease and disability. If more people are involved in clinical trials, it may reduce the time it takes to make new interventions widely available.

By taking part in a clinical trial, you can contribute to the advancement of scientific knowledge and, in some cases, to improved health for yourself or others with the same disease or condition.

Australia conducts internationally recognised high-quality clinical trials. Australian clinical researchers have a wealth of knowledge and expertise that is helping to improve health care both in Australia and around the world. Clinical research also improves our health care service by improving patient care practices.

Why be part of a trial if you are healthy

Healthy people may choose to participate in order to help others, to contribute to improved health care or to contribute to the advancement of scientific knowledge. Sometimes they have a personal interest in the specific trial or they might have a friend or family member with the disease or condition.

Like any volunteer work, clinical trials can also be a way to give back to the community.

Although volunteering to help improve the lives of family, friends or others is an extraordinary gesture of kindness, potential participants should think carefully about the demands on their time and the risks and benefits (if any) before enrolling in a clinical trial.

Why be part of a trial if you have a disease or condition

Patient participants with a disease or condition may decide to participate in clinical trials to contribute to better understanding of, or better treatment or a potential cure for their disease or condition. In some cases, clinical trials can provide access to new interventions before they are widely available.

Trials also offer the hope of developing better interventions or tests for a particular disease or condition, so that even if a trial does not provide a benefit for an individual, it may provide benefits for others with the disease in the future.

As a patient participant, even when you receive the highest quality care, you may also benefit from additional support and attention provided by clinical trial staff who understand your disease or condition

Potential benefits and potential risks

Potential benefits

In addition to helping to find better treatments, therapies and diagnostic tests, clinical trials can also provide direct benefits for participants, including:

• The opportunity to be given a new intervention that may be better for your condition or that has fewer side effects than what you are receiving now. Trials may offer participants access to the newest interventions before they are made available to the general public.
• The chance to play an active role in your own health care and gain a greater understanding of your disease or condition.
• Advice, care and support from trained clinical staff who understand your disease or condition.
• Closer monitoring of your condition, care and treatment.

Clinical trials may also be valuable for people with rare or difficult-to-treat conditions for which there may be limited evidence about how the condition is best treated or managed.

It is important to note that there is no guarantee that any individual participant will receive any direct benefit from taking part in a trial.

Potential Risks

While some clinical trials require minimal time and effort from participants, others may require a major commitment and may involve discomfort or pain. Some interventions may also carry some risk. Some possible risks of participation in a clinical trial include:

• The new intervention in the clinical trial may not work for you.
• The new intervention may not be as effective as established interventions or standard care.
• There may be unpleasant, serious or even life-threatening side effects associated with the new intervention.
• The need for additional treatment, tests, hospital visits or complicated medication requirements arising out of your participation in the trial. For example, you may need to keep a symptom diary, collect 24 hour urine specimens or wear a monitor overnight.
• Depending on the type and phase of the trial, unanticipated risks due to limited use or testing of the intervention in humans.

The risks of a specific trial are described in detail in the participant information and consent form as part of the process of informed consent. This process involves one or more members of the research team explaining the risks of participating in the trial, answering any questions that you may have and providing a document that you will be asked to sign before participating in the research.

Potential participants should carefully consider the possible risks and benefits of participation. When considering the risks of a clinical trial, a person might choose to consider:

• what kind of harm may occur
• how serious the harm may be
• what the chance is of any harm occurring.

Clinical trials and children

Children can be participants in clinical trials. However, children are developmentally and physiologically different from adults and children’s responses to medical interventions and tests cannot always be predicted from information collected in clinical trials that only include adults.

Until recently, children were rarely included in trials of medical interventions and much is still unknown about how children respond to some medications, medical devices and tests. Therefore, clinical trials that are designed to test the effectiveness of interventions for children are important to ensure that children, too, can receive appropriate, safe and effective treatment and care.

Why enrol a child in a clinical trial?

Parents and guardians choose to enrol their children in clinical trials for a range of reasons, including a desire to provide optimal care for their child and to contribute to improving the treatment and care of other children.

A parent’s/guardian’s consent and the child’s assent

If you are thinking of enrolling your child in a clinical trial, it is important that you understand what is involved so that you can make informed choices — together with your child, if they are old enough. Your child’s health and safety is always a top priority and should be considered before agreeing to enrol them in any trial.

Children under 16 cannot give legal consent, which has to be given by a parent or guardian, but they can and should be involved in the decision. Children benefit from knowing what will happen, having a say and being listened to, even though they do not have the legal authority to make the decision to participate.

Young people over 16 can give legal consent to medical treatment; however, they usually cannot provide legal consent to participate in research until they are 18. Nonetheless, some Human Research Ethics Committees (HRECs) do allow mature young people under 18 to give their consent for some kinds of research.

When you are approached to give informed consent for your child to take part, your child may also be asked for their permission or agreement to take part in the clinical trial. This agreement is sometimes referred to as the child’s ‘assent.’ Assent should be obtained when the child is considered to have sufficient maturity to be able to express a view on whether they would like to take part in the research.

Both informed consent and assent require that children understand the research process and are informed about what they are expected to do or what will happen to them during the trial. In considering whether to agree to participate, children can express their views and any worries about participating in a trial and have their questions answered. Children should always be given information in a form that they can understand.

Getting information

Before a parent or guardian can give consent for a child to take part in a trial, it is important that the parent or guardian is given enough information to make an informed choice and an opportunity to ask as many questions as necessary. Staff cannot enter a child in a trial if the parent or guardian does not give their informed consent. There should never be any pressure placed on parents or guardians to give consent for their children to take part in a clinical trial.

Parents who are considering enrolling a child in a trial will be invited to talk with a scientist or health care professional on the research team. They may also wish to discuss their child’s participation in the trial with other family members and with the child’s doctor or other healthcare professional about the decision.