Phases of Clinical Trials
da Mahmoud H. Al-Johani
1. Phase II
1.1. Test what had been tested in phase one in a larger group of volunteers (100-500)
1.2. Objectives:
1.2.1. Further evaluate the safety
1.2.2. Evaluate effectiveness
2. Phase III
2.1. 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
2.2. Objectives:
2.2.1. Confirm efficacy
2.2.2. Monitor side effects
2.2.3. Compare with standard of care
2.2.4. Further safety assessment
3. For further information
3.1. Check Here:
3.2. Check Here:
4. Phase I
4.1. Researchers test new drug/ treatment/ protocols regime on a small group of healthy volunteers (50-<100)
4.2. Objective
4.2.1. Evaluate safety
4.2.2. Determine safe dosage range
4.2.3. Identify Side Effects
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