Kwon, Angela Eunyoung, Jaecheok Park, Gene Moo Lee. “How Does AI Change Drug Development? Evidence from Clinical Trial Phases and Drug Types,” Working Paper.
- Presentations: KrAIS (2025), CIST (2025), INFORMS (2025), UBC (2025), WISE (2025)
We examine how pharmaceutical firms’ AI capabilities influence drug development outcomes, focusing on clinical trials. Clinical trials progress through three phases that differ in regulatory scrutiny and evidentiary requirements. We measure firm-level AI capabilities using job postings and clinical trial outcomes using the number of trials initiated across phases. We find no significant overall effect of AI capabilities on clinical trial activity. However, this average relationship masks meaningful heterogeneity. AI capabilities are associated with increases in incremental innovation (refinement trials) but not radical innovation (new trials). These effects are stronger for biologics, where market incentives are high, than for small-molecule drugs, where learning hurdles are relatively low. AI capabilities also matter more in early-phase trials, where regulatory barriers are lower, and have no detectable influence in Phase III. This study contributes to the healthcare IS literature by identifying the nuanced and context-dependent business value of AI in drug development. It also offers practical guidance for pharmaceutical firms and policymakers on where AI investments are most likely to enhance R&D productivity.