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What is phase 2 of clinical trials and why is this important in drug development?

Phase 2 of clinical trials are studies to evaluate the effectiveness of an investigational drug / therapy and observe short-term side effects and risks. This stage usually includes a larger group of participants than in phase 1. It also includes participants affected by the disease or condition of interest as opposed to the unaffected volunteers utilized in phase 1. To learn more about phase 2 of clinical trials and why it is important for drug development, click on the links below.

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Relevant publications

Phase 2 Clinical Trial Design

• Mayo and Gajewski: Bayesian Sample Size Calculations in Phase II Clinical Trials Using Informative Conjugate Priors
• Lin and Shih: Adaptive Two-Stage Designs for Single-Arm Phase IIA Cancer Clinical Trials
• Sambucini: A Bayesian Predictive Two-Stage Design for Phase II A Clinical Trials
• Taylor et al.: Comparing an Experimental Agent to a Standard Agent
• Fazzari et al.: The Phase II/III Transition. Towards Proof of Efficacy in Cancer Clinical Trials
• Pangeas et al.: An Optimal Two-Stage Phase II Design Utilizing Complete and Partial Response Information Separately

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