Repurposing Registries: Completeness of Real-World Data for Regulatory and HTA Purposes in Three Cancer-Focused Registries

Abstract

Despite developments in supporting the identification and selection of fit-for-purpose registries, a translational gap remains between the original purposes of clinically focused registries and their current and future expected use in policymaking. This study aimed to assess the extent to which cancer-focused registries collect essential data elements for regulatory and Health Technology Assessment (HTA) processes. Using literature and expert input, a reference dataset of essential data elements was developed. Completeness of data elements in this reference dataset was evaluated on the example of three European, cancer-focused registries, varying in type, coverage, and health system: the Cancer Centre Upper Austria (CCUA) registry, the Dutch Medication Audit (DMA), and the Portuguese Oncology Institute of Porto (RIC IPO Porto) registry. The evaluated registries exhibit clear differences in inclusion criteria driven by their specific aims. Data elements related to comorbidities, concomitant therapies, patient-reported outcome measures (PROMs), resource use, and safety outcomes were lacking partly or completely in all evaluated registries, highlighting the importance of developing disease-specific core datasets to which registry holders can benchmark their data collection. This study also highlights that the initial aims and design of registries impact their strengths and weaknesses in supporting regulatory and HTA decision-making. Optimally repurposing registry data requires capacity building for registry holders and regulatory/HTA stakeholders focusing on mutual understanding of aims, needs, and limitations. Additional research should address data interoperability, standardization, and data quality across registries.