Phases of Clinical Trials

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Phases of Clinical Trials by Mind Map: Phases of Clinical Trials

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

6. Prepared by:

6.1. Mr. Abdulaziz Abuhabshah

6.2. Dr. Weam Banjar

7. SaudiDent