What is clinical research?
Clinical research is generally carried out in phases: Phase 1, 2, 3 and 4.
Phase 1 studies:
- Enrolls a small number of healthy volunteers or patients
- Tests the safety of a test treatment and what happens to it in the human body
- Can last for around 6 to 12 months.
Phase 2 studies:
- Enrolls hundreds of patients
- Tests the effectiveness and safety of the investigational treatment
- Can last for 2 to 4 years
Phase 3 studies:
- Enrolls hundreds to thousands of patients
- Further tests the effectiveness and safety of the investigational treatment
- Can last for 5 to 10 years
Upon successful completion of Phase 3 studies, the sponsor submits an application to the health authorities of one or more countries to approve the investigational treatment as a medicine or medical device.
Phase 4 studies:
- Conducted when the treatment has been approved for use
- Enrolls hundreds to thousands of patients
- Monitors the long term effects of the treatment
- Can last for 4 to 8 years.
Phases of clinical research
