A flexible blueprint for the future of drug development.

摘要

The current model for developing newdrugs is becoming unaffordable. Costs to research and develop new drugs are steadily increasing, resulting in higher prices and mounting concerns among payers about affordability and cost-effectiveness. Ultimately this spiral in costs threatens new and effective drugs reaching patients. The problem is global and urgent.Recent years have seen various initiatives to streamline development processes2"4 but, without a coherent and agreed blueprint into which they fit, progress has been insufficient to stem the rising tide of delays and costs. After discussions with an expert group of regulators, drug developers, patients' representatives, and value-assessment agencies, I set out such a basic blueprint, as a basis for discussion, refinement, and more concerted action (figure).