PARTICIPATING IN CLINICAL RESEARCH

If you or someone you know has been diagnosed with cancer, you may want to know about clinical trials or other clinical research studies that may be available at Peter Mac.

At Peter Mac, there are many different types of research studies being undertaken. These include;

• Laboratory research, which is research carried out by scientists using equipment such as microscopes. It is the basis of clinical research and includes research looking at the roles of various molecules and genes in starting and stopping cancer. Our lab scientists also develop new treatments and drugs, and test these are safe and effective in tissues and cells before they are used by people.
• Translational research, which aims to get new treatments or medical approaches into practice,
• Clinical trials research, which may include areas of disease prevention, screening, diagnostics and treatment,
• Cancer experiences type research, which includes;
  • Behavioural research, which looks at how cancer impacts people emotionally and socially, or may examine individual characteristics, lifestyle or other factors that may affect the risk of developing or surviving cancer, and
  • Health service research, which examines how people get access to healthcare professionals and services, how much care costs and what happens to patients as a result of these factors.

For a free practical guide on ‘Understanding Clinical Trials and Clinical Research’, please visit the Cancer Council of Victoria website.

If you or your cancer doctor find a suitable clinical research study or trial you want to join, you will be asked to supply details to confirm you are eligible for that study. If it looks like you are eligible for a clinical research study, an appointment will be made with your cancer doctor, a research nurse or a researcher working on the study.

Taking part in a study

All clinical research projects have a detailed plan which describes the purpose of the study, how it will be conducted and who can join the study. This is called the ‘study protocol’.

To join a study, there may be certain characteristics or eligibility criteria that must be met. For example, these may be related to age, cancer type, symptoms or side effects experienced, previous medical history etc. Sometimes people are unable to join a study because certain characteristics limit their ability to take part in the trial or may increase the risk of them having a bad reaction to the treatment or intervention, for example if they are pregnant or have high blood pressure etc.

For a clinical trial of a drug or new treatment, you may need a ‘referral’ from your treating cancer doctor.

Informed consent

Before you join a research study, your doctor, nurse or another researcher will ask your permission. The process of giving your permission is called ‘informed consent’. Providing ‘informed consent’ means that you understand the purpose, and the risks and possible outcomes of the study.

Informed consent means that;

Step 1. You have received written information about the study called ‘Participant Information’. This information includes;

• The purpose of the study
• Who can or can not participate in the study
• Who is running the study, for example the name of the researcher and their research institution
• Who have approved the study; all clinical research must be approved by a Human Ethics Research Committee
• Who is funding the research
• What you need to do in the study, including any tests or other procedures
• How long the study will last
• Information about possible side effects or any risks of joining the study
• Who you can contact if you need further information, or have a problem or complaint
• How your privacy, and medical and study records and data will be protected in the study
• Your rights to withdraw from the study

Step 2. Following an explanation of the study you will be given time to read the ‘Participant Information’ and ask any questions you may have about the study. If you agree to take part in the study, you will be asked to sign the study consent form. Signing a consent form is not like signing a contract because you may at any time withdraw from the study at any time – see below.

What can I expect?

At the start

• You may need to complete some tests to check that the research study is suitable for you. This may include medical tests (for example a blood test) or you may need to complete a questionnaire.
• You should read the ‘Participant Information’ provided to you. You may want to discuss the information with your family, friends or doctor.
• You may ask your cancer doctor, the research nurse or the researcher any questions you may have about the study.
  Here are some questions you may wish to ask

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• You will need to provide ‘informed consent’ to join the study.

During the study

• Please follow the instructions and directions you have been given for the study. This ensures that the information and results that are collected from you are as accurate and reliable as possible. This may include attending your appointments, taking prescribed medicines and completing questionnaires and other paperwork.
• You may need to complete more tests and paperwork than you would normally expect. This is because we are monitoring your health and wellbeing while you are participating in the study.
• You may also participate in an interview which asks you about your experiences, and how you are feeling emotionally and physically.

After the study

• You may need to complete more tests and paperwork after the study has been completed. This is because the researchers of your study are interested in long-term information about your health and wellbeing.
• After the study you will return to recieving the type of treatment that is currently the best option for you or you may need to have normal check-ups with your GP (usual doctor). What happens next depends on the stage of your cancer and what your cancer specialist thinks is the best care for you.

If you would like to continue with the experimental treatment, you must ask your cancer specialist whether this is possible. Whether you are able to continue on an experimental treatment after the study is over depends on many things. For example, the stage or phase of the study, the study results and whether the treatment worked for you. In the case of drug or other therapeutic trials, it may also depend on whether the sponsor (for example, the pharmaceutical company) is prepared to continue providing the treatment.

Can I withdraw from a clinical research study?

Yes. You can withdraw from a clinical research study or trial at any time. You can also decide to withdraw from a clinical research study or trial for any reason.

You will not be penalised if you decide to withdraw from a clinical research study or clinical trial. If you withdraw from a clinical research study or clinical trial, you will continue to receive the type of treatment that is currently the best option for you.

Are there other ways to participate in research?

Yes, you may be able to participate in a clinical research study as a ‘consumer representative’.

Consumer representatives can be patients, former patients, and family members and friends of patients.

Consumer representatives support research studies by providing a consumers’ perspective. This is an important role that helps us achieve better health and research outcomes.

If you are interested in being a consumer representative on a research project or elsewhere at Peter Mac, please visit our ‘Getting Involved: Consumer Participation’ webpage or email our Manager of Consumer Engagement at commparticipation@petermac.org

Australian Cancer Trials Online: free information service displaying the latest clinical trials in cancer care across Australia

Australian Clinical Trials: A federal government site with general information for the public, researchers and industry

Cancer Cooperative Trials Groups: These groups conduct world-class multi-disciplinary research for cancer control to inform clinical practice and improve the survival and quality of life of cancer patients.

Cancer Council Australia and State and Territory Councils: These groups undertake a broad range of activities including research (and funding research), developing and providing to cancer patients and the broader community resources, developing and supporting cancer prevention and early detection programs, providing patient support and more.

• Cancer Council Australia
• Cancer Council Australian Capital Territory
• Cancer Council NSW
• Cancer Council Qld
• Cancer Council SA
• Cancer Council Tasmania
• Cancer Council Northern Territory
• Cancer Council Victoria (CCV)
• Cancer Council WA

Clinical research glossary: This glossary has been prepared by the U.S.A National Institutes of Health

ClinTrial Refer (various apps available in the iTunes store and Google play): For disease specific Apps, search ClinTrial Refer in your App store.

Consumer Learning: This website was developed by the federal government to enhance the contribution of people affected by cancer to clinical trials research

Medicines Australia: Representing the Australian pharmaceutical industry, this website includes a list of questions and answers about clinical research

National Cancer Institute (NCI): The NCI coordinates the National Cancer Program in the U.S.A. Their website contains useful information including discussion topics, statistics, a comprehensive cancer glossary and resources for caregivers.

PRE-ACT (Prepartory Education About Clinical Trials): PRE-ACT provides clinical research information through a series of short videos.

Victorian Cancer Trials Link database: This website link provides up-to-date information on active and upcoming clinical trials at Peter Mac through the Cancer Council of Victoria’s website

We extend our thanks to the CCV for their resources in developing the content of this webpage.