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What is phase 1 of clinical trials and why is this important in drug development?

Phase 1 of clinical trials are the initial studies evaluating the safety, dosage range and side effects of investigational drugs / therapies in humans. During phase 1 the metabolism and pharmacologic action of a drug or therapy is examined in a small group of humans. Usually the participants in phase I are ‘healthy’ or unaffected volunteers. To learn more about phase 1 of clinical trials and why it is important for drug development, click on the links below.

• International Psoriasis Council: Understanding the Different Phases of Clinical Trials

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Therapies for Rare and Neglected Partnership Program

• Therapies for Rare and Neglected Diseases, NIH: FAQ About the TRND Program
• Therapies for Rare and Neglected Diseases, NIH: Apply to TRND