An Operational Playbook for GCC Real-World Evidence Registries: From Framework to Field-Ready Practice

Abstract

Paper 1 of the GCC RWE Operational Series (three-paper series). Across the Gulf Cooperation Council (GCC), a decade of health-data infrastructure investment is converging into a new regulatory reality: locally generated, registry-grade real-world evidence (RWE) is now required to support marketing authorization, health technology assessment, and formulary access. Extrapolated foreign RWE no longer satisfies the evidentiary threshold. This paper argues that the constraint on GCC real-world evidence submissions is not data availability — Malaffi, Nabidh, Riayati, and the Saudi Cancer Registry hold submission-grade data today. The constraint is registry-governance discipline: the operational architecture that turns those data assets into evidence a regulator will accept. The paper introduces the GCC Registry Readiness Model — five operational pillars, fifteen success criteria, and five measurable key performance indicators, derived from the author's peer-reviewed multi-country RWE operational track record across Asia-Pacific (2017–2023) and translated for the Gulf's specific regulatory, data-infrastructure, and jurisdictional environment. Target audiences: regulators and health technology assessment bodies designing evidence-review pathways; sponsors and CROs commissioning GCC-native registries; site management organizations, academic centers, and investigators executing on the ground. Published open-access under Creative Commons Attribution 4.0 (CC BY 4.0).