OZTRIALS CLINICAL RESEARCH
HELPING FIND BETTER THERAPIES TOGETHER
We are a private, independent clinical trial research site formed to conduct phase II-IV clinical trials in various therapeutic areas, based in Sydney’s Inner West (Drummoyne).
Our mission is to provide clinical trial participants with excellent medical care, and provide Sponsors with the highest quality research services.
- For Patients
Participating in clinical trials can be very rewarding for the individual and also supports the search for improved and new medicines.
If you are interested in finding out about clinical trials which may be relevant to you or a loved one, please get in touch with us to find out about our current and upcoming studies.
Find out more about our currently enrolling clinical trials here…
- For Sponsors
Oztrials is a private clinical research unit setup to assist clinical trial Sponsors with their pipeline goals.
Oztrials Clinical Research can offer support with clinical trial HREC submissions, Patient Recruitment, Site Management through to project completion in various therapeutic areas.
Contact us today for clinical trial feasibility, and to discuss your next project needs!
- Partners
Oztrials welcomes constructive collaborations with local and international Contract Research Organisations (CROs), other research sites, Institutes & Non-profit groups, Site Management Organisations (SMOs), medical professionals, external labs, Universities and beyond to work together on clinical trials projects conducted to Australian TGA annotated ICH GCP (Good Clinical Practice) guidelines and the National Statement on Ethical Conduct in Human Research.
PATIENTS' FREQUENTLY ASKED QUESTIONS
Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention* and what side effects might occur. This helps to determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available.
Clinical trials might also compare existing interventions, test new ways to use or combine existing interventions or observe how people respond to other factors that might affect their health (such as dietary changes).
The World Health Organization (WHO) definition for a clinical trial is
‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’.
Clinical trial interventions include but are not restricted to
- experimental drugs
- cells and other biological products
- vaccines
- medical devices
- surgical and other medical treatments and procedures
- psychotherapeutic and behavioural therapies
- health service changes
- preventive care strategies and
- educational interventions.
Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease.
*The word ‘intervention’ will be used to refer to interventions, treatments and tests throughout this website.
New interventions that help people to live longer, have less pain or be free of disability are only possible because of the willingness of people to participate in clinical trials. Both healthy participants and those diagnosed with a disease or condition are needed to help find new ways to diagnose, prevent, treat or cure disease and disability. If more people are involved in clinical trials, it may reduce the time it takes to make new interventions widely available.
By taking part in a clinical trial, you can contribute to the advancement of scientific knowledge and, in some cases, to improved health for yourself or others with the same disease or condition.
Australia conducts internationally recognised high-quality clinical trials. Australian clinical researchers have a wealth of knowledge and expertise that is helping to improve health care both in Australia and around the world. Clinical research also improves our health care service by improving patient care practices.
WHY BE PART OF A TRIAL IF YOU ARE HEALTHY
Healthy people may choose to participate in order to help others, to contribute to improved health care or to contribute to the advancement of scientific knowledge. Sometimes they have a personal interest in the specific trial or they might have a friend or family member with the disease or condition.
Like any volunteer work, clinical trials can also be a way to give back to the community.
Although volunteering to help improve the lives of family, friends or others is an extraordinary gesture of kindness, potential participants should think carefully about the demands on their time and the risks and benefits (if any) before enrolling in a clinical trial.
WHY BE PART OF A TRIAL IF YOU HAVE A DISEASE OR CONDITION
Patient participants with a disease or condition may decide to participate in clinical trials to contribute to better understanding of, or better treatment or a potential cure for their disease or condition. In some cases, clinical trials can provide access to new interventions before they are widely available.
Trials also offer the hope of developing better interventions or tests for a particular disease or condition, so that even if a trial does not provide a benefit for an individual, it may provide benefits for others with the disease in the future.
As a patient participant, even when you receive the highest quality care, you may also benefit from additional support and attention provided by clinical trial staff who understand your disease or condition.
COPYRIGHT: © COMMONWEALTH OF AUSTRALIA 2014
This work is licensed under a Creative Commons Attribution 3.0 Australia License
For anyone interested in being part of a clinical trial, the first step is finding out more about trials in general and what is involved in a particular clinical trial. It is a good idea to seek out information from a number of sources.
There is a wealth of information available on this and other websites about clinical trials in general, why a person may want to be part of a clinical trial, the ethics and regulation of clinical trials in Australia and how to find a trial that is relevant.
WHO TO TALK TO
You can talk to any of the health professionals involved in your care — general practitioners (GPs), specialists, or nursing or allied health professionals. They should be able to provide general information about clinical trials and may have information on clinical trials that is relevant you.
Support groups or consumer health organisations with an interest in a particular disease or condition that you are interested in may also have information on trials, or be able to provide contact information for other patients who have been involved in trials.
QUESTIONS TO ASK
If you are thinking of being part of a clinical trial, you should know as much as possible about the trial and your involvement in it. You can discuss your questions with your doctor and with the research team. You may also find some of the answers to your questions in the participant information and consent form.
When you plan to discuss participation
- consider taking a family member or friend along for support and for help in asking questions or recording answers
- plan what to ask ahead of time, but don’t hesitate to ask any new questions that you think of while you’re there
- write down your questions in advance to make sure you remember to ask them all
- write down or record the answers, so that you can review them whenever you want
- remember that you can ask further questions to the team running the trial at any time
- remember that you can withdraw from the trial at any time and resume other treatment, if that is recommended.
HERE ARE SOME QUESTIONS THAT YOU MAY WANT TO ASK:
ABOUT THE TRIAL
- What is the aim of the trial and how will it help people?
- Has the intervention been tested before and, if so, what was the outcome?
- Will the trial use a placebo (a ‘dummy’ treatment), standard care or another established intervention as the controlto compare with the new intervention?
- Who is funding the trial?
YOUR INVOLVEMENT
- How might this trial affect my daily life? How much of my time will be needed?
- What kinds of tests and experimental interventions are involved?
- Will I have to complete questionnaires or keep a diary?
- Will I need to spend time in hospital?
- Will I need to take time off work or school?
- Where will the trial be conducted and will I have to travel to be part of it?
- Will I be able to take my regular medications while participating in the trial?
- How long is the trial expected to last? How long will I have to be part of it?
- What will happen if I stop the trial intervention or leave the trial before it ends?
- Who will be in charge of my care? Who can I contact for support and information during the trial? Will someone be available 24 hours a day?
RISKS
- What are the risks of taking part in this trial? What are the possible side effects of the trial intervention?
- How do the possible risks, side effects and benefits in the trial compare with my current treatment or care?
- If people receiving one intervention in the trial respond much better than people receiving the other intervention or standard care, will all participants be given access to the more effective intervention?
Costs
- Who will pay for the experimental intervention?
- Will I be paid to participate in the trial?
- Will my expenses be covered?
- If there are complications that arise from the trial, who is responsible for paying for any costs that are associated with them?
AFTER THE TRIAL
- What follow-up care is available after the trial?
- How long will it be before the results of the trial are known?
- How do I find out the results of the trial?
- Will I have access to the experimental intervention after the trial if I wish to continue with it?
COPYRIGHT: © COMMONWEALTH OF AUSTRALIA 2014
This work is licensed under a Creative Commons Attribution 3.0 Australia License