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Editorial
. 2019 Nov;13(6):995-1000.
doi: 10.1177/1932296819839996. Epub 2019 Apr 3.

Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes

David C Klonoff  1 , Alberto Gutierrez  2 , Alexander Fleming  3 , David Kerr  4
Affiliations
Editorial

Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes

David C Klonoff et al. J Diabetes Sci Technol. 2019 Nov.

Abstract

Randomized clinical trials (RCTs) are no longer the sole source of data to inform guidelines, regulatory, and policy decisions. Real-world data (RWD), collected from registries, electronic health records, insurance claims, pharmacy records, social media, and sensor outputs from devices form real-world evidence (RWE), which can supplement evidence from RCTs. Benefits of using RWE include less time and cost to produce meaningful data; the ability to capture additional information, including social determinants of health that can impact health outcomes; detection of uncommon adverse events; and the potential to apply machine learning and artificial intelligence to the delivery of health care. Overall, combining data from RCTs and RWE would allow regulators to make ongoing and more evidence-based decisions in approving and monitoring products for diabetes.

Keywords: diabetes; randomized clinical trials; real-world evidence; regulatory approval.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DCK is a consultant for Ascensia, EOFlow, Lifecare, Merck, Novo, Roche Diagnostics, and Voluntis. AG is Partner at NDA Partners and advices multiple device companies in regulatory issues. AF is Executive Chairman of Kinexum, which advises multiple health-product companies in the fields of metabolism, cardiovascular, oncology, and dermatology. DK is a Medical Advisor for Glooko and Vicentra and a Consultant for NovoNordisk and Sanofi.

References

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