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Wednesday, July 01, 2020 7:08:46 PM
Clinical Research Phase Studies
Phase 1
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Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
Approximately 70% of drugs move to the next phase
Phase 2
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Study Participants: Up to several hundred people with the disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
Approximately 33% of drugs move to the next phase
Phase 3
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Study Participants: 300 to 3,000 volunteers who have the disease or condition
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of adverse reactions
Approximately 25-30% of drugs move to the next phase
Phase 4
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Study Participants: Several thousand volunteers who have the disease/condition
Purpose: Safety and efficacy
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