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Better Decisions for Phase 1 Clinical Trials Using Integrated Design Models

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There is considerable pressure to increase the success rate and to address inefficiencies in clinical research to reduce the cost of development and strengthen the drug pipeline. Yet at the same time, new molecules are presenting more and more challenges that make such improvements difficult.

Innovative "adaptive" clinical trial designs utilizing "manufacturing on demand" have emerged as a promising solution to improve speed and efficiency of the drug development process. However, these need to be selected carefully, for example, when there is also the need for enabling technologies to resolve bioavailability limitations. Innovative trial designs, on-demand manufacturing, real-time clinical data-based dose adjustments, and partnering with experienced formulators and Contract Research Organizations (CROs) can enable faster, better decision-making during phase 1 clinical trials.

EXECUTIVE SUMMARY HIGHLIGHTS:

Understand the difference between adaptive and other phase 1 trial designs
Learn how costs and timelines can be reduced through the use of formulation ‘design space’ and ‘manufacturing on demand’ approaches
Identify the formulations best suited to this approach and review real-world case studies highlighting the benefits to innovator companies