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Tools and Methods for Real-World Evidence Generation: Pragmatic Trials, Electronic Consent, and Data Linkages

Author

Curtis JR1, Foster PJ2, Saag KG2. Rheum Dis Clin North Am. 2019 May;45(2):275-289. doi: 10.1016/j.rdc.2019.01.010.

Author Information

1 Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: jcurtis@uab.edu.

2 Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.

Abstract

Real-world evidence requires use of new tools and methods to support efficient evidence generation. Among those tools are pragmatic trials, utilization of central/single institutional review board and electronic consent, and data linkages between diverse types of data sources (eg, a trial or registry to administrative claims or electronic medical record data). This article reviews these topics in the context of describing several exemplar use cases specific to rheumatology and provides perspective regarding both the promise and potential pitfalls in using these tools and approaches.