Clinical Trial Phases Explained

Understand what Phase 1, 2, 3, and 4 clinical trials mean. Browse trials by phase with AI-powered analysis and plain English summaries.

Trial Distribution by Phase

93 total clinical trials tracked.

PhaseDescriptionTrialsShare
Phase 1 Safety & dosage (20-80 participants) 14
15%
Phase 2 Effectiveness (100-300 patients) 25
27%
Phase 3 Large-scale pivotal (300-3,000+) 10
11%
Phase 4 Post-approval monitoring (1,000+) 5
5%
N/A Phase not applicable or not specified 39
42%

Phase 1 — Safety & Dosage (14 trials)

First-in-human testing with 20-80 participants. The primary goal is to evaluate safety, determine safe dosage ranges, and identify side effects. About 70% of drugs pass this phase.

Phase 2 — Effectiveness (25 trials)

Expanded testing with 100-300 patients who have the target condition. Researchers evaluate whether the treatment works and monitor short-term side effects. Only about 33% of drugs pass this phase.

Phase 3 — Large-Scale Pivotal Trials (10 trials)

Large-scale studies with 300-3,000+ participants. These trials confirm effectiveness, compare against standard treatments, and collect comprehensive safety data. Successful Phase 3 trials can lead to FDA approval.

Phase 4 — Post-Approval Monitoring (5 trials)

Post-marketing studies with 1,000+ participants. These trials monitor long-term safety, effectiveness across diverse populations, and detect rare adverse effects after a drug reaches the market.

Early Phase 1 & Phase 1/Phase 2

Some trials are classified as Early Phase 1 (initial safety/pharmacology studies) or Phase 1/Phase 2 (combined early safety and efficacy studies that blend elements of both phases).

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