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Abstract
Purpose Systemic lupus erythematosus (SLE) is an autoimmune disease with a broad range of clinical manifestations and a high unmet need. Real-world data on SLE are available and currently scattered across more than 50 registries across the globe. The Lupus Federated Data Network (LupusNet) is an interdisciplinary initiative that aims to standardize data and harmonize methodology to create a large, global SLE database from existing registries. This initiative will allow analysis of real-world data across lupus registries worldwide.
Methods The central paradigm of LupusNet is a federated model whereby the data reside with the respective registries/data owners and analyses are executed at the local center. As data from different sources have different infrastructures, the Observational Medical Outcomes Partnership (OMOP) common data model (CDM) will be used to standardize data into a common format. Standardization will reduce heterogeneity in data structure and semantics, allowing for uniform data analysis, collaborative research, large-scale analytics, and sharing of sophisticated tools and methodologies. LupusNet will include prospective, observational registries designed to capture real-world data on demographics, treatments, and outcomes in patients with SLE. Other data, including data originating from randomized clinical trials, will also be part of this initiative.
Results Currently, 6 registries representing 4 regions of the globe and ~30,000 lupus patients are engaged at the start of this initiative. Examples of the types of data from each registry that are available for standardization and harmonization in LupusNet are shown in Figure 1. Other lupus registries that may be interested in participating in this initiative should contact the authors. Participating registries are not required to collect all types of data to be included in the initiative. Contact the LupusNet team at www.lupusnet.org.
Example of data collected from lupus registries and clinical trials
Conclusions Through the standardization of global registry data, LupusNet hopes to demonstrate the potential of real-world evidence to answer important questions related to SLE with the ultimate goal of improving patient outcomes.
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