Abstract
Real-world evidence from multinational disease registries is becoming increasingly important not only for confirming the results of randomized controlled trials, but also for identifying phenotypes, monitoring disease progression, predicting response to new drugs, and early detection of rare side effects. With new open access technologies, it has become feasible to harmonize patient data from different disease registries and use it for data analysis without compromising privacy rules. In this article, we provide a blueprint for how a clinical research collaboration can successfully use real-world data from existing disease registries to perform federated analyses. We describe how the European Severe Asthma Clinical Research Collaboration SHARP fulfilled the harmonization process from non-standardized clinical registry data to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) and built a strong network of collaborators from multiple disciplines and countries. The blueprint covers organizational, financial, conceptual, technical, analytical and research aspects and discusses both the challenges and the lessons learned. All in all, setting up a federated data network is a complex process that requires thorough preparation, but above all, it is a worthwhile investment for all clinical research collaborations, especially in view of the emerging applications of artificial intelligence and federated learning.
Footnotes
This manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.
Conflict of interest: Dr. Bansal has nothing to disclose.
Conflict of interest: Dr. Berret reports that SHARP is an ERS clinical research consortium and foundings are from 5 pharma partners (GSK, Sanofi, Chiesi, Novartis and Teva).
Conflict of interest: Dr. Wagers reports personal fees from Kings College Hospital NHS Foundation Trust, personal fees from Academic Medical Research, personal fees from AMC Medical Research BV, personal fees from Asthma UK, personal fees from Athens Medical School, personal fees from Boehringer Ingelheim International GmbH, personal fees from CHU de Toulouse, personal fees from CIRO, personal fees from DS Biologicals Ltd, personal fees from ÉCOLE POLYTECHNIQUE FÉDÉRALE DE LAUSANNE, personal fees from European Respiratory Society, personal fees from FISEVI, personal fees from Fluidic Analytics Ltd., personal fees from Fraunhofer IGB, personal fees from Fraunhofer ITEM, personal fees from GlaxoSmithKline Research & Dev Ltd, personal fees from Holland & Knight, personal fees from Karolinska Institutet Fakturor, personal fees from KU Leuven, personal fees from Longfonds, personal fees from National Heart & Lung Institute, personal fees from Novartis Pharma AG, personal fees from Owlstone Medical Limited, personal fees from PExA AB, personal fees from UCB Biopharma S.P.R.L., personal fees from Umeå University, personal fees from Univ. Hosptial Southampton NHS Foundation Trust, personal fees from Università Campus Bio-Medico di Roma, personal fees from Universita Cattolica Del Sacro Cuore, personal fees from Universität Ulm, personal fees from University of Bern, personal fees from University of Edinburgh, personal fees from University of Hull, personal fees from University of Leicester, personal fees from University of Loughborough, personal fees from University of Manchester, personal fees from University of Notthingham, personal fees from Vlaams Brabant, Dienst Europa, personal fees from Imperial College London, personal fees from Boehringer Ingelheim, personal fees from Breathomix, personal fees from Gossamer Bio, personal fees from Astrazeneca, personal fees from CIBER, personal fees from OncoRadiomics, personal fees from University of Leiden, personal fees from University of Wurzburg, personal fees from Chiesi Pharmaceutical, personal fees from University of Liege, personal fees from Teva Pharmacauticals, personal fees from Sanofi, personal fees from Pulmonary Fibrosis Foundation, personal fees from Three Lakes Foundation, outside the submitted work.
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- Received April 4, 2022.
- Accepted June 28, 2022.
- Copyright ©The authors 2022
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