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A clinical trial is a research study where participants are assigned to one or more health-related interventions to evaluate the effects on health outcomes.

Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to:

  • Drugs
  • Cells and other biological products
  • Surgical procedures
  • Radiologic procedures
  • Devices
  • Behavioural treatments
  • Process-of-care changes
  • Preventive care

Clinical trials are conducted in a series of steps called phases. Each phase has a different purpose and helps researchers answer different questions. There are four phases of clinical trials:

  • Phase I studies usually test new interventions for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
  • Phase II studies test interventions that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
  • Phase III studies are conducted on larger populations specifically in clinical settings and in different regions and countries, and are often the step right before a new treatment is approved.
  • Phase IV studies take place after country approval and there is a need for further testing or evaluation in a wide population over a longer timeframe.

Clinical trials are conducted only after the drug or intervention has been tested for safety in a non-clinical setting (such as a laboratory), and an ethics committee has approved the trial. Clinical trials are carefully regulated and are governed by clearly defined legal and ethical codes.

While receiving care at GV Health you may be invited to take part in a clinical trial. In consenting to participate and support our research, you will be helping us to determine better care and health outcomes for yourself as well as for future generations.

Patients participating in clinical trials receive expert monitoring and continual support. Studies have actually demonstrated better clinical outcomes for clinical trial participants irrespective of treatment allocation (active intervention or control group).

For more information about clinical trials at GV Health, please see our relevant resources or contact clinicaltrials@gvhealth.org.au

For more information about regional oncology clinical trials, please visit https://regionaltrialsnetwork.org/

FAQs for Patients and Families

GV Health is committed to helping find new ways to prevent, diagnose, treat or manage diseases and conditions so that we can provide the best possible evidence-based health care and outcomes for people in our community.

While receiving care at GV Health you may be invited to take part in a research study. In volunteering to participate in and support our research, you will be making a real difference in health care for future generations.

Clinical research studies play a vital part in telling us more about health conditions, so we can come up with new and better ways to care for people. Clinical research contributes to the advancement medical knowledge and the findings from studies can change the way people are cared for across Australia and the world.

The two primary types of clinical studies are observational and experimental or interventional. In observational studies, researchers observe study participants and record the effects of their current treatment without making any changes or collect information without intervening with anything. Experimental or interventional studies are also called clinical trials. During these studies the enrolled participants may be intervened with drugs, devices, cells and other biological products, surgical procedures, radiologic procedures, behavioural treatments, process-of-care changes, preventive care, etc.

Clinical trials and research undertaken at GV Health reflect the unique health concerns and needs of our community. Conducting this vital research provides opportunities for the local community to access new or better treatments and enables us to continually improve clinical care in order to provide the best possible health services and outcomes for our patients.

Involvement in clinical research and trials can range from something as simple as completing a questionnaire or giving researchers permission to look at your medical history, to providing blood, urine or other biological samples, or testing a new medicine, device or medical treatment, use of medicine in a different way, or other clinical interventions. The level of involvement depends on what the researchers are investigating. Sometimes researchers may also ask permission to use leftover tissue or blood samples that are collected as part of their routine medical care.

All research must be approved by an ethics committee which is responsible for assessing the ethical principles of research to protect the participants in research.

Before agreeing to participate in a clinical trial, it is important for you to understand all the details so that you can decide if participating is right for you. Potential known risks and the benefits, including obligations for yourself and your research team, must be clearly explained to you before you agree. This is called informed consent.

The information you need is usually given to you in a clear, easy-to-read, Patient Information Statement provided by the people conducting the study. This should cover details such as the study’s purpose, duration, required procedures and appointments, and the key contacts.

You will be given the opportunity to ask your study doctor or research team any questions about the study. You should ask about anything that is not clear to you.

After you have received, read and understood all the relevant information, you will be asked to sign a voluntary written informed consent form. This is required to participate in any study.

Participation in clinical research is completely voluntary. No matter whether or not you decide to participate, you will continue to receive the same high-quality medical care from your treating team.

You also have the right to change your mind at any time. Should you decide to withdraw from a clinical trial or research, you will continue to be treated without prejudice.

The Australian Charter of Healthcare Rights describes what consumers, or someone they care for, can expect when receiving health care. These rights apply to all people in all places where health care is provided in Australia. This includes public and private hospitals, day procedure services, general practice and other community health services.

For more information about the Charter, please visit here.

Download the Australian Charter of Healthcare Rights PDF 

Please feel free to ask your research team any questions you might have about your participation in clinical research studies. Common questions include:

  • What does my participation mean?
  • How does my participation help research?
  • Will I be treated differently if I do not wish to participate?
  • What are the benefits or risks of taking part in this clinical trial?
  • Who will have access to my information and how will my information be used?
  • If anything goes wrong, how and to what extent I will get support from the research team?

For more information, please contact clinicaltrials@gvhealth.org.au

For Sponsors and Partners

Effective partnerships between public hospitals, research institutes, industry sponsors and universities are vital in overcoming the health challenges facing our community.

GV Health values partnerships with organisations across Australia and internationally. Our relationships with industry, universities and collaborators, provides experience with commercially sponsored clinical trials, collaborative investigator-initiated clinical trials, and other clinical research projects.

All clinical trials at GV Health are conducted in accordance with the International Conference on Harmonisation Guidance on Good Clinical Practice (CPMP/ICH/135/95) and the National Statement of Ethical Conduct in Human Research (2007), along with all subsequent updates.

GV Health encourages and actively participates in sponsored and investigator-initiated clinical trials. Our health service cares for people throughout the Goulburn Valley and the catchment of GV Health. This region demonstrates a wide variation in demographic (diverse multicultural and higher proportion of Aboriginal and Torres Strait Islander population in regional Victoria) and socioeconomic indicators, providing a diverse pool of trial participants volunteering for clinical trials at our organisation.

GV Health is currently conducting clinical trials in oncology, haematology, anaesthesiology, general and geriatric medicine, addiction medicine, endocrinology and allied health. We are always looking to increase clinical trial activity in other departments across the organisation.

For more information about research partnerships with GV Health, please contact research.ethics@gvhealth.org.au

For more information about clinical trials, please contact clinicaltrials@gvhealth.org.au

  • ADDRESS

Goulburn Valley Health
Graham Street
Shepparton, 3630

  • CONTACT

Emergency: 000

Phone: (03) 5832 2322

Nurse on call: 1300 606 024
for non life threatening injury/illness

  • RELEVANT LINKS

Regional Trials Network