Understanding Clinical Trials and Research
Cancer research in Australia
Australia is an international leader in cancer research and has contributed to many of the major advances in cancer prevention, treatment and support. The involvement of people affected by cancer has been the key to much of this progress.
Before any clinical research can begin, it has to show it is scientifically worthwhile and fair to the people participating. The organisation, institution or company responsible for the overall conduct of a clinical trial is known as the trial sponsor. Their responsibilities include developing, financing and managing the trial, and ensuring the trial meets all legal, ethical and insurance requirements.
In 2016–18, more than $252 million was awarded to 589 individual cancer research projects, with $187 million (74%) of that from the Australian Government. Cancer Council is the largest non-government funder of cancer research in Australia.
The funding for cancer research comes from a range of government and non-government sources:
National Health and Medical Research Council (NHMRC) – This is the Australian Government’s main funding body for medical research. The NHMRC awards grants to researchers based on their ability to investigate important questions about human health. The NHMRC also helps run the Medical Research Future Fund.
Medical Research Future Fund (MRFF) – The Australian Government set up this ongoing research fund in 2015, and it had grown to $20 billion by 2020. The fund earns interest that can then be used to pay for important health and medical research projects.
Cancer charities – State and territory Cancer Councils and other charities receive donations from the public, as well as grants from government bodies and private companies. This funds their own cancer research and allows them to financially support cancer research carried out by other institutions.
Government bodies – Researchers can apply for grants from other national, state and territory government agencies. The grants fund the research and allow them to employ cancer trials staff.
Universities, medical research institutions and clinics – These sometimes use their own funds and staff to support research.
Private companies (industry funded) – Companies producing medicines and medical equipment run trials to check their products are safe and effective before applying for licences to sell them. Private companies may also fund research in partnership with a university or other research institution, or for goodwill (philanthropic) reasons.
All research involving people must follow a set of international standards. These standards cover how the research is designed, conducted, recorded and reported. They ensure that people taking part in the research are safe, their privacy is protected, information is collected to the highest standard, and the results are reliable.
In addition, clinical trials and other clinical research must follow a set of standards called Good Clinical Practice (GCP). GCP is the same anywhere in the world where clinical research is conducted.
For more information about Australian guidelines for research involving people, visit the Australian Clinical Trials website.
How research is approved
Before a clinical trial or other research study can begin in Australia, it has to be approved by a number of committees:
Research or scientific review committee – This committee decides whether the study has social and scientific value and checks that it has been designed to produce valid scientific results.
Human research ethics committee (HREC) – This committee confirms that the interests of participants are protected and that researchers will run the study in a fair, honest and neutral (impartial) way. It ensures researchers won’t force people to participate, and that the risks of the research generally don’t outweigh the benefits.
The members of the HREC are always independent of the researchers and come from a variety of professions and the general community.
Research governance review – This is a review that checks all the locations (sites) where the research will take place. It is done by a research governance officer, who makes sure there are enough resources to carry out the proposed research and that the staff members involved are qualified. The governance officer approves the research to begin at each site.
The study may also be monitored by outside agencies such as pharmaceutical companies, independent advisory committees, research institutions and auditors. These bodies ensure that the research is carried out properly.
Conflict of interest
A conflict of interest may arise in any research project. This means the interests of an organisation or researcher could influence the results of the research. Researchers are required to declare any possible or actual conflicts of interest. All research projects should include details of how a conflict of interest will be managed.
Changes to research
Sometimes changes need to be made to the research before or after the research is approved. The HREC may ask the research team to make changes to the proposed research before it can go ahead.
After the research has been approved, if the research team want to make any changes during the trial or study, it must go through ethics approval again before the changes can take place. If the changes are made, participants already taking part may need to sign another consent form to show that they have been told about the changes and still agree to be involved.
The Therapeutic Goods Administration (TGA) is an Australian Government department that regulates all medicines sold in Australia. The TGA must be notified of any new drug that is going to be used in a clinical trial. If the trial shows that the drug is safe and effective, the TGA may then approve it for use outside of a clinical trial. For more information about the role of the Therapeutic Goods Administration, visit the TGA website.
Sometimes people want to contribute to research without joining a clinical trial or other research study. They may have been affected by cancer in the past – either directly or indirectly – and want their experience to help shape future cancer research. Researchers refer to these people as “consumers” to distinguish them from patients or others recruited to a study.
The role of consumers in research has increased over the years. Consumers are now involved in identifying priorities for research and helping to decide which projects should be funded. They may also be asked to review a draft participant information sheet or provide feedback on what a proposed study is asking of participants.
Cancer Council offers an online training course known as the Cancer Consumer Involvement in Research Training Program. This teaches people how to work with researchers.
Cancer Australia developed the National Framework for Consumer Involvement in Cancer Control. This initiative includes a web-based toolkit for cancer researchers and other professionals who involve consumers in their work.
The Australian Clinical Trials Alliance offers a consumer involvement toolkit as well as information about clinical trials in community languages.
Consumer advocacy organisations are available at a national level and in some states. They focus on improving cancer treatment through active consumer participation. To learn more, visit them online at:
If you would like to get involved in research as a consumer, contact one of these organisations or call Cancer Council 13 11 20.
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This information is reviewed by
This information was last reviewed January 2022 by the following expert content reviewers: A/Prof Brett Hughes, Senior Staff Specialist, Medical Oncology, Royal Brisbane and Women’s Hospital and The Prince Charles Hospital, and Associate Professor, The University of Queensland, QLD; Christie Allan, Clinical Trials Lead, Cancer Council Victoria, VIC; Dawn Bedwell, 13 11 20 Consultant, Cancer Council Queensland, QLD; Joanne Benhamu, Senior Research Nurse, Team Lead, Lung, Colorectal and Palliative Care Trials, Parkville Cancer Clinical Trials Unit, Peter MacCallum Cancer Centre, VIC; Louise Dillon, Consumer; Sabina Jelinek, Clinical Nurse Research, St John of God Murdoch Hospital, WA; Chloe Jennett, Program Coodinator, Cancer Research, Cancer Council NSW; Carmel McCarthy, Consumer; Alison Richards, Research Unit Manager, Medical Oncology Clinical Trials Unit, Flinders Medical Centre, SA; Prof Jane Ussher, Translational Health Research Institute (THRI), School of Medicine, Western Sydney University, NSW; Prof Janette Vardy, Medical Oncologist, Concord Cancer Centre, and Professor of Cancer Medicine, The University of Sydney, NSW.