therapeutic innovation & regulatory science

Early Clinical Development Planning via Biomarkers, Clinical Endpoints, and Simulation: A Case Study to Optimize for Phase 3 Dose Selection

Methodological Extensions of Phase 2 Trial Designs Based on Program-level Considerations: Further Development of a Case Study in Neuropathic Pain

DIA’s Adaptive Design Scientific Working Group (ADSWG) Best Practices Case Studies for “Less Well-understood” Adaptive Designs

Addressing Challenges and Opportunities of “Less Well-Understood” Adaptive Designs