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Abstract:
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Drug development is a long, complex, and costly process. The majority of the cost arises from the phase 2 and phase 3 clinical development. Reducing the phase 2 and 3 failure rates would greatly reduce the average drug development cost. Effectively utilizing the longitudinal surface model will improve estimation efficiency and result in more efficient early phase study design. We show this through a model-based multiple ascending dose (MAD) design. This type of MAD design allows relatively informative efficacy data available prior to phase 2 development, and hence can serve as a proof-of-concept (POC) study. This approach may greatly reduce the drug development cycle time without increasing the risk of Phase 2 development.
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