The Governance Gap: Democratizing Drug Development Through Decision Architecture

Abstract

Drug development is most exposed to governance failure where it can least afford it, in global health. The field has more predictive power than at any point in its history and roughly the same failure rate it had a decade ago. We argue that this paradox persists because the field has invested heavily in prediction science while neglecting decision architecture. Programs do not typically fail because data were absent. They fail because signals were not integrated, concerns were not escalated, and decisions were made by whoever happened to be in the room, with whatever experience they happened to carry. This concentration of decision quality in a small number of experienced individuals is the deepest structural vulnerability in translational medicine. The global health programs, small biotechs, and academic translational groups that most need world-class governance are the ones least likely to have it. The domains in which programs fail are finite, recurring, and encodable. The reflexes that distinguish an experienced development leader from a capable but junior scientist can be externalized into structured interrogation systems. The result is not the replacement of expert judgment but its democratization: making the architecture of evidence-driven and rational decisions available to every development team. This paper sets out the case for structured decision architecture as the underbuilt layer of translational governance, and as the route to more equitable drug development in global health.