Patients & Carers
Background Clinical trials examine new cancer treatments through patient-based research. They provide the critical data to determine whether potential new treatments are safe and effective. A wide range of treatments are studied in clinical trials ranging from drugs through to radiological and surgical methods, as well as preventative options for combating cancer. Clinical trials are run by research teams at universities, hospitals, pharmaceutical companies and private institutions.
Depending on the stage of the treatment being studied, trials can encompass thousands of patients on an international basis. Patients participating in trials receive at minimum the best available treatments, and sometimes better, depending on the improved efficacy of the drug or other treatment being trialled.
All clinical trials are required to include an informed consent process for patients that are considering taking part. Informed consent ensures that participants are fully aware of the nature of the trial, the commitment required and any potential risks involved. If you are interested or have been approached to participate in a clinical trial, please speak with your physician about the options available to you.
Clinical trials are monitored by the Australian government through the Therapeutic Goods Administration (TGA), especially those which test products that are not yet approved for certain usages. Researchers must notify the TGA before conducting any such trials under the Clinical Trials Notification (CTN) Scheme or alternatively apply for approval under the Clinical Trials Exemption (CTX) Scheme.
Australian medical oncologists are actively engaged in national and international cancer clinical trials with a strong focus on oncology drugs. The Medical Oncology Group of Australia's membership include world class leaders in clinical trials and associated global cancer research activities through agencies such as the NHMRC at University of Sydney and Cancer Trials Australia.
Clinical trials are essential for the advancement of oncological knowledge and the improvement in quality of life for cancer patients. The Medical Oncology Group of Australia is committed to supporting clinical trials in the region, and since 2004 has spearheaded the Australia & Asia Pacific Clinical Oncology Research Development (ACORD) Workshop. The ACORD Workshop helps motivated researchers to develop and finesse the necessary skills for designing innovative and effective clinical trials, as well as fostering collaboration across international boundaries.
Glossary of Commonly Used Clinical Trials Terms
|Randomised controlled trials (RCT)||Treatments are assigned randomly to patients in a trial. Patients do not choose which treatments they receive. The aim is to compare new treatments against current standard treatments by reducing the potential for bias.|
|Control group||The group that does not receive the new treatment being studied but receives the current standard treatment.|
|Protocol||A protocol details the number of patients, the duration, the trial, the treatments, tests and how the results will be interpreted for each trial. Protocols are reviewed and approved by human research ethics committees before a trial is initiated.|
|Eligibility criteria||Requirements that ensure patients enrolling in a clinical trial share similar factors such as general health, age, stage of cancer, hormonal status, and previous treatment. When patients share the same characteristics, it gives researchers greater confidence that the results of the study are because of the treatment(s) studied rather than other factors.|
|Single-blind study||Where only the research team know whether patients are receiving the standard treatment or the new treatment under trial.|
|Double-blind study||Neither the patients nor the research team know which treatments they are receiving - either the new treatment or the current standard treatment. When safety concerns arise, treatment can be ‘un-blinded'.|
|Informed consent||The process by which a patient learns about a clinical trial - including benefits, risks and side effects - before they decide whether or not to be involved.|
|Phase I, II, III and IV||Trials are conducted in four sequential phases. Phase I and II trials involve small numbers of patients, including those for whom current treatments are no longer viable. Phase III trials are large-scale trials involving thousands of patients where new treatment options are compared with current treatments. New treatments become part of standard care when their value is proven in Phase III trials. Phase IV trials continue to collect information about treatments that have become part of standard care after they have passed through Phase III.|
|Placebo||A placebo is used only if the trial is seeking to find out whether a new treatment is better than doing nothing (the placebo). A placebo is not usually appropriate for Phase III trials.|
Adapted by the Breast Cancer Network Australia from the Coalition of Cancer Cooperative Groups (US) Patient Toolkit Glossary
Resources – Patients & Carers
The Breast Cancer Network Australia (BCNA) provides a useful and accessible Clinical Trials Fact Sheet with a focus on patients and carers.
BCNA’s publication Beacon 39 includes stories of patients who have been involved in clinical trials. More stories are available on the BCNA website.
Breastcancer.org, a US based non-profit organisation for breast cancer education has a useful clinical trials information sheet.
Resources – Medical Professionals
Therapeutic Goods Administration – Clinical Trials Section
The TGA provides a number of resources including a Clinical Trial Handbook and Frequently Asked Questions webpage. This site also has the required forms for CTN and CTX reporting available for download.
Australian New Zealand Clinical Trials Registry (ANZCTR)
The ANZCTR is an online register of clinical trials being undertaken in Australia and New Zealand. The ANZCTR includes trials from the full spectrum of therapeutic areas trials of pharmaceuticals, surgical procedures, preventive measures, lifestyle, devices, treatment and rehabilitation strategies and complementary therapies.
Clinical Trials Search.org – Australian Clinical Trials
Clinical Trials Search.org is an international database of current clinical trials, including listings from Australia and beyond.
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
The NHMRC Clinical Trials Centre, a clinical research organisation, runs large multicentre investigator-initiated clinical trials, takes part in trials of national and international collaborative trial groups and contributes expertise to trials run by others.
HealthInsite - Clinical Trials Resources
HealthInsiteis an Australian Government initiative, funded by the Department of Health and Ageing, and includes 45 titles relating to clinical trials from trusted sources such as the Cochrane Collection.
Clinical Trials Groups in Australia & New Zealand
Cooperative oncology trials groups are responsible for many of the cancer related clinical trials that take place in the region. Please find below the contact details for the 13 largest cooperative groups and their related websites.
Australasian Gastro-Intestinal Trials Group
Australasian Leukaemia and Lymphoma Group
Australasian Lung Cancer Trials Group
Australia and New Zealand Melanoma Trials Group
Australia New Zealand Gynaecological Oncology Group
Australian and New Zealand Children’s Haematology and Oncology Group
Breast Cancer Trials
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Australasian Sarcoma Study Group
Cooperative Trials Group for Neuro-oncology
Psycho-Oncology Co-operative Research Group
Trans Tasman Radiation Oncology Group (TROG)
The Victorian Cancer Trials Link
International Clinical Trials Programs
Breast European Adjuvant Studies Team (BREAST)
Breast International Group (BIG)
Cancer Therapy Evaluation Program (CTEP) – USA
Cancer Trials Support Unit (CTSU) – USA
Children’s Oncology Group (COG) – USA
European Organisation for the Research and Treatment of Cancer (EORTC)
International Breast Cancer Study Group
National Cancer Research Network – UK
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