Clinical Trials
Before a therapy or drug treatment that has been developed in the laboratory can be prescribed by a doctor, it must first be proven safe and effective in humans. A clinical trial is a scientific study of how the new therapy works in people. To ensure the safety of the volunteers involved in the study, all clinical trials must have been granted ethical approval by governing health authorities before they can proceed.
There are various categories or phases of clinical trials, dependent on the number of participants involved and the purpose of the study.
- Phase I - involves less than 10 participants; goal of trial is to test the safety of a treatment
- Phase II - involves up to 40 participants and is designed to assess how well the treatment works
- Phase III - involves 100 - 1000 participants and looks at how effective the new treatment is in comparison to current therapies
- Phase IV - number of participants varies, can be up to several thousand; ongoing monitoring of the treatment after it has been approved for standard use to further evaluate its long-term safety and effectiveness
The Malaghan Institute has participated in a phase I/II trial for non-Hodgkins lymphoma and a phase III trial for melanoma and is currently involved in a phase I trial for glioma (brain cancer).
