Clinical Trial Mechanics & Costs
Bringing a novel therapeutic to market takes an average of 10.5 years and over $1 billion. Understanding where and why candidates fail is crucial for risk modeling.
Phase Breakdown
| Phase | Primary Goal | N Size | Est. Success Rate |
|---|---|---|---|
| Preclinical | In vitro/in vivo toxicity & efficacy | Animal Models | N/A |
| Phase I | Safety, Dosage, Pharmacokinetics | 20-100 (Healthy) | 60% |
| Phase II | Efficacy in patients, side effects | 100-300 | 30% |
| Phase III | Large scale efficacy, comparison to SOC | 300-3,000+ | 58% |
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