Quantitative Sciences in the Model-Informed Era: From Parallel Functions to a Shared Decision System.

Abstract

Model-informed drug development increasingly depends on collaboration among clinical pharmacology, statistics, pharmacometrics, and quantitative systems pharmacology. Yet functional silos, distinct leadership structures, and divergent goals can reduce collaboration to late, parallel deliverables that constrain decision architecture. This Perspective defines a shared decision system as an operating model in which quantitative and clinical disciplines jointly define the question, context of use, evidentiary role, uncertainty standards, and accountability for model-informed evidence.