The Current Landscape and Emerging Applications for Real-World Data in Diagnostics and Clinical Decision Support and its Impact on Regulatory Decision Making.

Autor: Baumfeld Andre E; Roche Diagnostics, Santa Clara, California, USA., Carrington N; Roche Diagnostics, Indianapolis, Indiana, USA., Siami FS; Medical Device Innovation Consortium, Arlington, Virginia, USA., Hiatt JC; Medical Device Innovation Consortium, Arlington, Virginia, USA., McWilliams C; Roche Diagnostics, Washington, DC, USA., Hiller C; Medical Device Innovation Consortium, Arlington, Virginia, USA., Surinach A; Genesis Research, Hoboken, New Jersey, USA., Zamorano A; Datavant, San Francisco, California, USA., Pashos CL; Genesis Research, Hoboken, New Jersey, USA., Schulz WL; Yale School of Medicine, New Haven, Connecticut, USA.
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2022 Dec; Vol. 112 (6), pp. 1172-1182. Date of Electronic Publication: 2022 Apr 29.
DOI: 10.1002/cpt.2565
Abstrakt: Real-world data (RWD) and real-world evidence (RWE) are becoming essential tools for informing regulatory decision making in health care and offer an opportunity for all stakeholders in the healthcare ecosystem to evaluate medical products throughout their lifecycle. Although considerable interest has been given to regulatory decisions supported by RWE for treatment authorization, especially in rare diseases, less attention has been given to RWD/RWE related to in vitro diagnostic (IVD) products and clinical decision support systems (CDSS). This review examines current regulatory practices in relation to IVD product development and discusses the use of CDSS in assisting clinicians to retrieve, filter, and analyze patient data in support of complex decisions regarding diagnosis and treatment. The review then explores how utilizing RWD could augment regulatory body understanding of test performance, clinical outcomes, and benefit-risk profiles, and how RWD could be leveraged to augment CDSS and improve safety, quality, and efficiency of healthcare practices. Whereas we present examples of RWD assisting in the regulation of IVDs and CDSS, we also highlight key challenges within the current healthcare system which are impeding the potential of RWE to be fully realized. These challenges include issues such as data availability, reliability, accessibility, harmonization, and interoperability, often for reasons specific to diagnostics. Finally, we review ways that these challenges are actively being addressed and discuss how private-public collaborations and the implementation of standardized language and protocols are working toward producing more robust RWD and RWE to support regulatory decision making.
(© 2022 Roche Diagnostics. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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