What is a clinical trial?
All our current treatments start out as investigational therapies. We rely on the results from clinical trials to bring these treatments to market. This is only possible with the help of patients who volunteer to take part in clinical trials. The more people in our clinical trials, the faster new treatments can become available to the community.
Clinical trials are medical studies that involve regular people like you and me. We use clinical trial results to develop new treatments, interventions, or tests to detect, treat or manage various diseases and medical conditions.
Some trials examine how people respond to a new treatment and identify possible side effects. This helps us determine how a new treatment works, whether it’s safe, and if it’s better than treatments already available.
Clinical trials might also compare existing treatments, test new ways to use or combine existing treatments, or observe how people respond to other factors that might affect their health (such as dietary changes).
Other trials look at ways to diagnose diseases earlier, or how to prevent the onset of particular diseases and medical conditions.
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.
- The World Health Organization (WHO)
Clinical trial treatments
These include (but are not restricted to):
- medical devices
- biopharmaceuticals (e.g. vaccines)
- surgical and other medical treatments and procedures
- psychotherapeutic and behavioural therapies
- health service changes
- preventive care strategies and
- educational interventions
Treatments begin as ‘experimental’ and move to ‘standard’ along a clinical pathway that’s checked and regulated at every stage. In the early stages, the new treatment is tested in a small number of people to assess safety and effectiveness. If the results are promising, the treatment moves to later stages of testing where we collect more information on effectiveness and possible side effects by increasing the number of people in the clinical trial.
Most modern medical treatments are a direct result of clinical research. New treatments for all diseases and conditions — including cancer, heart disease, high blood pressure and asthma — have been developed through clinical research. Computer simulation and animal testing can only tell us so much. Without clinical trials, we can’t determine whether new treatments are effective or safe, or whether a diagnostic test works properly. If we want to understand how a new medical treatment or diagnostic test works on the human body, there’s no substitute for working with actual humans.
Clinical trials also make it possible to test and monitor the effects of a treatment on large numbers of people. This ensures that any improvement is a result of the treatment for many people, and not a random effect for one person.
Clinical trials often lead to new treatments that help people live longer and have less pain or disability. Clinical trials also help improve health care services by raising standards of treatment. Doctors and medical staff involved in clinical trials are continually training to provide best practice medical care.
New treatments that help people live longer, healthier lives are only possible because of the willingness of volunteers to take part in clinical trials. We need volunteers 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 for new treatments to become available to the general population.
People participate in clinical trials for a variety of reasons:
- To contribute to the advancement of scientific knowledge
- To help researchers find better treatments for others in the future
- To potentially receive a benefit from the treatment for their condition
- To gain access to new treatments before they become widely available
- To receive additional care and support by clinical trial staff at no extra cost.
GenesisCare conducts internationally recognised, high-quality clinical trials. Our doctors and research staff have a wealth of knowledge and expertise that is helping to improve health care in Australia and around the world. Our clinicians believe that new treatments should only be adopted once adequate assessment takes place to confirm their effectiveness, safety, and cost.
All research conducted by GenesisCare conforms to the Ethical Principles of the Declaration of Helsinki and to international Good Clinical Practice guidelines. Before research can go ahead, it’s approved by an independent ethics committee that operates according to the guidelines issued by the National Health and Medical Research Council (NHMRC Guidelines).
You will never be ‘out of pocket’ for participating in a trial. Every patient gets the standard of care treatment – alone or combined with a new treatment. Our job is to work with you to make sure that new treatments live up to their claims. Together, we can improve future health outcomes for all Australians and the wider global community.
It’s important you know that you are not obliged in any way to take part in a clinical trial. If you do take part, you can withdraw at any time without it affecting your ongoing medical care.