OEN: Multi-center, international, real-world evidence studies performed using health records without data pooling—The use of a common data model and shared analytical methods.

Authors

null

Bethany Levick

Leeds Cancer Centre, Leeds Teaching Hospitals Trust, Leeds, United Kingdom

Bethany Levick , Sue Cheeseman , Eun Ji Nam , Haewon Doh , Subin Lim , DongKyu Kim , Francois Bocquet , Elodie Martin , Paul Kubelac , Patriciu Achimaș-Cadariu , Rita Calisto , Marta Magalhães , Sven Becker , Andrea Wolf , Nicolas Niklas , Mariana Guergova-Kuras , Geoff Hall

Organizations

Leeds Cancer Centre, Leeds Teaching Hospitals Trust, Leeds, United Kingdom, Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea, ALYND, Yonsei University Health System, Seoul, South Korea, Institut de Cancérologie Ouest, Nantes, France, "Prof. Dr. Ion Chiricuţă" Institute of Oncology, Cluj-Napoca, Romania, Portuguese Oncology Institute of Porto (IPO-Porto), Porto, Portugal, Frankfurt University, Frankfurt, Germany, Universitätsklinikum Frankfurt am Main, Frankfurt, Germany, IQVIA Commercial GmbH & Co. OHG, Frankfurt Am Main, Germany, IQVIA, La Defense, France

Research Funding

Other
IQVIA

Background: The value of real-world evidence derived from the care of patients managed outside the context of clinical trials is well recognised. However, the ability to link data from multiple centres, especially those from different countries, is complicated by complex legal and information governance differences. The Oncology Evidence Network is a collaboration of large hospital centres, with strong clinical informatics capabilities in six countries in Europe and Asia working with the support of an industrial partner to provide high quality, real world data reflecting routine clinical care. We have developed an efficient workflow based on a study-specific common data model (CDM) clinically validated at each site and analysed with a single analysis script, which embeds a set of data quality rules. Local implementation allows each centre to generate analytical outputs aligned across the different sites without the need for any patient level data to leave the participating site. This approach has been designed and tested in Epithelial Ovarian Cancer (EOC) patients. Methods: A CDM was agreed using expert advisors from each centre. Clinical alignment was achieved through iterative assessment of clinical vignettes, to ensure common definitions of clinical assessment, prognosis, and treatment algorithms in EOC patients. A data guide detailing variable level derivations and validation rules, general data coding principles, and conversions/codes from international coding systems was developed. The analysis scripts were implemented as a bespoke package (OpenOvary) in R. The package includes functions to validate the data against the CDM, and generate a standard output including tables, numerical summaries and Kaplan-Meier analysis of progression and overall survival. Results: 2,925 patient records from 6 centres across 6 countries were included in the study with 27 key data items curated by each centre. Treatment data is available detailing relevant surgical procedures and their outcomes, and regimens of SACT throughout patients’ care from diagnosis to death. Data completeness was generally high for key data items, with missing data ranging from 0-16% for FIGO stage at diagnosis and 0-14% for tumour morphology. The CDM and R script will be made publicly available for other centres to adopt and facilitate analysis of their local data. Conclusions: This collaboration has brought together a substantial body of data describing the care and outcomes for EOC patients. A CDM and flexible shared analysis approach enabled unified analysis and reporting whilst avoiding the transfer of patient level data and its pooling into a common database. The process of clinical and data alignment has generated a replicable model for rapid extension to other study centres to join the EOC study, or application to other disease areas.

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Care Delivery and Regulatory Policy

Track

Care Delivery and Quality Care

Sub Track

Clinical Informatics/Advanced Algorithms/Machine Learning

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr e13554)

DOI

10.1200/JCO.2021.39.15_suppl.e13554

Abstract #

e13554

Abstract Disclosures