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Phase 2c: Expedited Development for All

This white paper proposes a new development pathway that replaces phase 3 trials for most drugs, not just rare and orphan indications, and offers ideas on increasing efficiency and success rates now. The phase 2c development pathway would offer advantages including earlier revenue generation for sponsors, reduced risk vs. phase 3 trials, help covering phase 2c costs, incentives to identify biomarkers, early collection of evidence of reimbursability and earlier patient access to new medicines. Pointers on optimizing programs under current constraints address topics such as making the most of end-of-phase-2a meetings, managing go/no-go decisions, optimizing dose selection and utilizing adaptive design and operations.

Download Phase 2c: Expedited Development for All – Accelerating Clinical Development Now and in the Future and learn about a proposed new expedited development pathway and practical steps to address clinical development challenges now:

 

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