Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data
Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data
Challenge
Comparative analyses of real-world data face persistent threats from investigator bias when study teams have unblinded access to results—a challenge that no structured methodological construct had yet formalized into a reproducible, audit-ready workflow.
Solution
Target RWE developed and published the staging and clean room constructs: a staged checkpoint system for progressive data review combined with a blinded independent committee that directs protocol amendments without exposure to unblinded results, demonstrated using Amgen-sponsored data.