An overview of cancer research

When cancer patients, carers and survivors, as well as people not affected by cancer, take part in research, it helps researchers learn more about cancer and ways to treat it.

Many people diagnosed with cancer who join a clinical trial or another research study do so because they want to help improve outcomes for others in the future, as well as for themselves.

Adults and children can take part in different ways, including:

• consenting to their medical records and personal information being accessed
• doing surveys and interviews
• being involved in a clinical trial
• agreeing to be examined regularly by health professionals
• allowing samples of cells or tissue taken during tests or treatment to be used for research outside of their own medical care.

All research studies, including clinical trials, have guidelines setting out who can take part. These are known as the eligibility criteria.

Most cancer research involves current patients, but some studies focus on cancer survivors, carers, family members, people at risk of cancer or people who have not been affected by the disease.

Anyone under the age of 18 needs permission from a parent or guardian before joining a research study.

To make sure results reflect Australia’s diverse population, it is important that research involves people of all ages, genders and sexualities, as well as people from a wide range of social, economic, racial and cultural backgrounds.

Cancer research is carried out in many places, including hospitals, treatment centres, laboratories and universities.

Sometimes you can be involved in cancer research from home. For example, you might have treatment or medicines mailed to you, or you might be asked to fill in a survey or complete a telephone or face-to-face interview.

Tele-trials for cancer

In Australia, some people are now taking part in clinical trials that use telehealth. This means that the research team use telephone or video calls to talk with patients and with local health professionals who are delivering part of the trial.

Clinical trials that use telehealth are sometimes called tele-trials. They were developed to make joining a clinical trial easier for people in rural and remote locations, but they can make it more convenient for anyone to take part.

You can talk to your cancer specialist about whether there is a tele-trial you could join. If you are already involved in a clinical trial, you could ask if parts of it can be delivered by telehealth.

A team of people work on clinical trials, and some of their roles overlap. If you decide to join a clinical trial, you may have contact with all or some of the people listed below. In most cases, your cancer specialist will continue to look after your overall cancer care while you are on the clinical trial.

Investigator

• also known as a researcher – there are usually a number of investigators/researchers involved in a clinical trial
• develops and plans research studies, and obtains, analyses and publishes the results
• may have a background in medicine, nursing, science, psychology, allied health, consumer advocacy or complementary therapies
• the principal investigator is responsible for conducting the trial at their hospital or university, ensuring patients are safe and the trial is properly run; is usually a doctor or senior academic with expertise in the field of research
• a co-investigator works in partnership with the principal investigator in helping run the trial
• the coordinating principal investigator oversees research that is taking place at more than one study site, e.g. at two or more hospitals

Nurse or research assistant

• may be called a clinical trials nurse, a clinical research nurse or a research assistant
• coordinates finding people for the trial (recruitment) by talking to potential participants, making sure they are eligible and explaining the purpose of the trial
• arranges appointments for tests, treatments or to see the specialist
• makes sure all necessary paperwork is completed once you have agreed to join a trial
• provides emotional support
• acts as a link between the patient and the researchers or the health care team
• may also be the main contact person for the trial
• larger clinical trials or hospitals have a dedicated clinical trials nurse, but smaller ones might not

Study coordinator

• may be called a clinical research coordinator or clinical trials coordinator
• may be combined with the nursing role
• may have a science or nursing degree (or similar)
• ensures the trial meets ethical and legal requirements
• applies for grants and manages budgets
• reviews the detailed plan for the trial and organises records

Cancer specialist

• may be a medical oncologist, surgeon, radiation oncologist or haematologist
• supervises your treatment, follow-up and overall care
• usually is also the principal investigator or the coordinating principal investigator

Other professionals

• a pharmacist stores and dispenses trial medicines, monitors their effect on patients and provides advice; may conduct laboratory research
• allied health practitioners and complementary therapists may give advice or treatment if the study is investigating non-medical treatments such as counselling, nutrition, massage, physiotherapy and acupuncture

There are many advantages to being involved in a clinical trial or other research study. Depending on the type of research, the benefits may include:

• knowing you have made a valuable contribution to helping others in the future
• joining programs or having medicines or other treatments that are not readily available outside of the study and may be better than the current standard treatment for that disease
• getting access to expensive drugs that your specialists recommend but that are not currently subsidised by the Pharmaceutical Benefits Scheme (PBS)
• seeing your treatment team, including specialists, more often
•  taking an active role in your health care
• learning new ways to improve your lifestyle
• improving or maintaining your quality of life
• feeling that you have tried all treatment possibilities.

Your doctor and the clinical trials or research nurse will discuss the possible advantages and disadvantages for you before you join a research study. Taking part in research doesn’t always mean you will be better off than before or compared to other people in a similar situation. Some people may not respond in the way researchers hope and will not benefit from being involved in the research.

In some clinical trials, people are divided into two groups. Only one group receives the experimental treatment, while the other group receives the current standard treatment. You won’t get to choose which treatment you have, but either way you will be monitored more frequently and closely  than usual.

Understandably, people want to know if there are any risks to taking part in research. Researchers must follow strict guidelines to make sure clinical trials and other research studies are as safe as possible for everyone involved. This is called their duty of care.

Before any research involving people can begin, it must be approved by a special group known as a human research ethics committee. As part of this process, researchers identify risks that might occur, such as possible side effects. They must also explain how they will closely monitor these risks and what will be done if problems occur. Before you agree to take part in research, you must be told about the risks, how you will be monitored for problems, and what will be done to help you if problems occur.

To reduce the risks, clinical trials are arranged in a series of steps known as phases.

From start to finish, clinical trials and other research studies may take several months or many years, but you may only need to be involved for some  of this time. For example, you might just have a single appointment lasting a couple of hours, or you may go to appointments every few weeks,  months or years. You may also have to do surveys at regular times. The participant information will set out what you would need to do and how long you would be involved.

Studies have what is known as a recruitment phase. This involves finding people to enrol in the study. It usually occurs over a few months or years until the required number of people have agreed to take part. The study is then closed to new participants.

After the treatment stage is over, there may be a follow-up phase. People may be followed up at set intervals for months or years. This allows researchers to understand the long-term effects of treatments, monitor the general health of the participants, and collect data about long-term survival and quality of life.

Ask your doctor whether being involved in the research will affect any other treatments you’re having or planning to have. These may include  standard cancer treatments; medicines for managing treatment side effects or symptoms of cancer or other conditions; and complementary therapies such as herbal or nutritional supplements or massage.

Your doctor may suggest stopping or delaying some treatments, or adjusting them in some way (e.g. by changing the dose).

It is important to let the research team know about any other medicines, supplements or complementary therapies you are having, as these may interact with the treatment being tested and cause harmful side effects.

Joining a clinical trial or other research study is free for Australian citizens and residents, and you should not be asked to pay to join.

The cost of trial-related treatment, tests and check-ups will be paid for by the organisation that is funding or conducting the research, sometimes called the sponsor. You will usually still have to pay for any treatments or tests you would normally pay for as part of your standard care. The participant information will outline any extra costs to you.

People participating in cancer research usually don’t get paid. This is because offering people money to join a clinical trial may put too much pressure on them to agree.

In some circumstances, you may be paid back for certain expenses (e.g. for travel, parking, light refreshments). These are known as out-of-pocket costs. The participant information will outline what expenses will be covered.

You may be interested in joining multiple clinical trials and other research studies. Check with the research team whether you can be part of more than one study at the same time. If you can, think about whether you’ll be able to commit to all the requirements of the studies. With clinical trials for medicines, you can usually only join one trial at a time.