What is a clinical trial?
The World Health Organization (WHO) defines a clinical trial as: ‘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'.
Most modern medical interventions are a direct result of clinical trials research. New interventions for many diseases and conditions — including cancer, heart disease, high blood pressure and asthma — have been developed through clinical research. Clinical trials often lead to new interventions becoming available that help people to live longer and to have less pain or disability.
Clinical trials can also help to improve health care services by raising standards of treatment. Doctors and hospital staff involved in clinical trials are continually trained to provide best practice patient care.
Australian clinical trials are recognised internationally for very high-quality patient care and are regulated by laws and codes of conduct that aim to protect trial participants and the integrity of the research.
All clinical research projects in Australia must be approved by a Human Research Ethics Committee (HREC), which checks that the research conforms to the requirements of the National Statement on Ethical Conduct in Human Research. Independent Ethics Committees ensure clinical trials can go ahead they need to be approved by independent ethics committees. These ethics committees operate in accordance with the guidelines issued by the National Health and Medical Research Council and ensure that clinical trials conform to the Declaration of Helsinki and to international Good Clinical Practice guidelines.
Are you interested in participating in a trial with Fusion Clinical Research?
Why participate in a clinical trial?
New medicines and medical devices that may 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. There are a number of possible advantages of participating in clinical trials. These can include:
- Gaining early access to new medicines not otherwise available;
- Obtaining the clinical trial medicine at no cost, at least during the trial;
- Receiving medical care associated with the clinical trial; and
- Contributing to the development of future life-saving or life-enhancing treatments.
- Remuneration for your time and inconvenience
- Like any volunteer work, clinical trials can also be a way to give back to the community.
Participation in clinical trials may provide these challenges:
- There may be side effects from the trial medicine;
- The trial medicine may not work;
- You may be placed in the control or reference group and therefore not receive the trial medicine until after the clinical trial has finished; and
- You may need to visit the GP practice more frequently for monitoring.
June - A Case Study
June is the mother of a son with Type I diabetes.
"When my son was diagnosed with diabetes I wanted him to get the right treatment and to improve his situation," she said. "When I saw a notice in the hospital seeking healthy volunteers for a Phase I clinical trial for a new diabetes drug and I immediately enrolled."
Having a family member with a disease is a common reason that motivates healthy volunteers to participate in a clinical trial. Feelings of helplessness and distress can be reduced in some people by contributing to the research effort. Being closely involved with a friend or a family member suffering from a disease also highlights the deep desire to access new treatments and medicines, bringing clinical trials into the conversation and raising awareness of their existence for the first time with some people.