Authors
Scott Flanders – ImmunityBio, Inc.
Phil Wakefield – Inizio
Angela Williams – Kyowa Kirin
Cerise James – MAPS Evidence Generation Domain Lead and FAWG Co-Chair, Owner of Tilghman James Group LLC
Introduction
Patient registries are organized systems that collect data for analysis and dissemination on individuals who share a particular disease, condition, or exposure.(1, 2) Unlike randomized controlled trials (RCTs) which enroll highly selected patients under strict protocols, registries observe real-world patient populations and potentially over longer periods than RCTs. This real-world orientation allows registries to address critical evidence gaps that RCTs are not designed to address, by capturing how treatments perform in routine practice across diverse patients and settings.(3) Registries have become vital tools in evidence generation for post-market surveillance, understanding disease natural history, demonstrating product value in reimbursement processes, and may inform clinical guidelines.