Phases of Clinical Trials
por Mahmoud H. Al-Johani
1. For further information
1.1. Check Here:
1.2. Check Here:
2. Phase I
2.1. Researchers test new drug/ treatment/ protocols regime on a small group of healthy volunteers (50-<100)
2.2. Objective
2.2.1. Evaluate safety
2.2.2. Determine safe dosage range
2.2.3. Identify Side Effects
3. Phase II
3.1. Test what had been tested in phase one in a larger group of volunteers (100-500)
3.2. Objectives:
3.2.1. Further evaluate the safety
3.2.2. Evaluate effectiveness
4. Phase III
4.1. Test what had been tested in phase II but to a larger group (several thousands). Participants might be allocated to either test or control group
4.2. Objectives:
4.2.1. Confirm efficacy
4.2.2. Monitor side effects
4.2.3. Compare with standard of care
4.2.4. Further safety assessment
5. Phase IV
5.1. Post-marketing surveillance
5.2. Reported by individuals/ community
5.3. Objectives:
5.3.1. Assess long term use and consumption