Clinical trials are an essential part of the development of new interventions and tests that may improve your health care, alleviate the symptoms of your disease or condition or improve the health care of others. 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:
Clinical trials are essential to the development of new medical treatments and diagnostic tests. Without clinical trials, we cannot properly determine whether new treatments developed in the laboratory or by using animal models are effective or safe or whether a diagnostic test may work properly. This is because computer simulation and animal testing can only tell us so much about how a new treatment might work, and are no substitute for testing in a living human body.
Clinical trials also allow testing and monitoring of the effect of a treatment on a large number of people to ensure that any improvement as a result of the treatment occurs for many people and is not just a random effect for one person. 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. Clinical trials often lead to new treatments that help people to live longer, and to have less pain or disability.
For example, clinical trials can help:
Clinical trials 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 as providing very high quality patient care.
Anyone taking part in a trial must be fully informed about the objectives of the research, what is expected of them and any risks and potential inconveniences that may be experienced during and after the trial. If you are thinking of being part of a trial, you should be given a participant information and consent form that contains details of the trial and your participation as part of the process of informed consent.
Trials must follow a carefully controlled protocol, which is a plan that describes what researchers will do in the study. As a clinical trial progresses, researchers may report the results of the trial at scientific meetings, to medical journals and to various government agencies. When they do this, the names and personal details of trial participants are kept confidential and are not disclosed.
Clinical trials are conducted, or ‘sponsored’, by a wide range of organisations. They include:
Regardless of the type of organisation sponsoring the clinical trial, the clinical trial must be approved and monitored under the ethical and good clinical practice guidelines set down by the Australia government.
Clinical trial participants may be reimbursed for travel and parking costs. Healthy volunteers participating in early stage testing may be paid for their time.
Clinical trials in Australia 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.