Abstract

Patient-centric drug development (PCDD) marks a transformative shift in the pharmaceutical industry, moving from a traditional "drug-first" approach to a "patient-first" model. This paradigm integrates patient insights at every stage—from early research to post-marketing surveillance—ensuring therapies are effective, tolerable, and aligned with real-world patient needs.

This paper provides a comprehensive analysis of PCDD, covering:

Evolution and regulatory drivers (FDA PFDD, EMA patient engagement frameworks)

Core strategies (patient engagement, decentralized trials, digital health, RWE)

Implementation challenges (data privacy, cost, cultural resistance)

Future directions (AI, blockchain, global patient registries)