Clinical Research

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