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

Conclusions:
For highly variable clinical endpoints, the fastest path should be to demonstrate PoC by biomarkers and then go directly to Ph2b to measure the target clinical endpoint.

Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Musser, B., Bolognese, J., Fayad, G. N., Bhattacharyya, J., Shentu, Y., Ederveen, A., Mixson, L., Patel, N. Tags: Clinical Trials Source Type: research