As a fundamental research institute, the Queensland Brain Institute plays a vital role in the ongoing development of improved treatments for a diverse range of diseases and conditions.
Normally, a treating clinician (ie registered medical specialist) would be a patient’s first point of contact for information about clinical trials. Patients are identified for trials through their treating doctor and information is published in QBI's regular newsletter.
Further, people are welcome to register their interest in any specific area of neuroscience research, should you wish to be considered for possible future trials.
To better understand the role fundamental research plays in the development of therapeutic drugs, we recommend you read the online information provided by the Australian Government’s Therapeutic Goods Administration. The site answers many commonly asked questions.
‘Fundamental’ or ‘basic’ scientific research is QBI's starting point for all new treatments. You may be able to participate in some of this research. Please visit our human study participants page to find out if you are eligible to participate in a research study.
Moreover, there are normally three stages in the clinical trial process.
Phase One Trials
If a new drug is identified as a possible candidate for further development, a Phase One trial is coordinated to test the treatment in people. Such trials involve only a few patients – who are administered a low dose of the drug. Slowly the dose is increased while the patients in the trial are carefully monitored and questioned about how the drug affects them. The aim is to find the safest dose level, while simultaneously discovering any risks or side effects associated with the new treatment.
Phase Two Trials
The next step, Phase Two, tests how well the treatment works with a specific condition. To minimise risk, these trials also involve only a few patients. Phase Two trials help to find the best way to treat the disease or condition with the least possible side effects.
Phase Three Trials
The final stage, Phase Three, only begins when the treatment has been shown to be safe and effective. Clinicians compare the new treatment with the best known treatments already available. Sometimes, clinicians working with Phase Three treatments involve hundreds of people from across the country or thousands of people from around the world. Phase Three trials are usually randomised controlled trials.
Randomised controlled trials
Most Phase Three trials are randomised controlled trials, which are thought to be the best way to test new treatments.
A ‘controlled’ trial compares a group which receives a promising new treatment with a group which receives the best standard treatment (this is known as the control group).
In a randomised controlled trial, none of the people in the trial knows which treatment they receive, because the treatments are assigned randomly. In a ‘blind’ trial or study, even the treatment team doesn’t know which patients receive which treatment. This helps avoid bias. Without blinding, patients who know they are taking the new treatment might expect it to work better. If they expect it to work well, they might report hopeful signs and not report bad signs. This would bias the trial by making the results look better than they really are.