A clinical trial is a research study where participants are assigned to one or more health-related interventions to evaluate the effects on health outcomes.
Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to:
- Cells and other biological products
- Surgical procedures
- Radiologic procedures
- Behavioural treatments
- Process-of-care changes
- Preventive care
Clinical trials are conducted in a series of steps called phases. Each phase has a different purpose and helps researchers answer different questions. There are four phases of clinical trials:
- Phase I studies usually test new interventions for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
- Phase II studies test interventions that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
- Phase III studies are conducted on larger populations specifically in clinical settings and in different regions and countries, and are often the step right before a new treatment is approved.
- Phase IV studies take place after country approval and there is a need for further testing or evaluation in a wide population over a longer timeframe.
Clinical trials are conducted only after the drug or intervention has been tested for safety in a non-clinical setting (such as a laboratory), and an ethics committee has approved the trial. Clinical trials are carefully regulated and are governed by clearly defined legal and ethical codes.
While receiving care at GV Health you may be invited to take part in a clinical trial. In consenting to participate and support our research, you will be helping us to determine better care and health outcomes for yourself as well as for future generations.
Patients participating in clinical trials receive expert monitoring and continual support. Studies have actually demonstrated better clinical outcomes for clinical trial participants irrespective of treatment allocation (active intervention or control group).
For more information about regional oncology clinical trials, please visit https://regionaltrialsnetwork.org/