Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes
Open accessAbstract
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.
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Only RCTs were included in the meta-analysis, which reduced the introduction of bias associated with nonrandomized studies but limits the generalizability of the findings in the real world.
“As well, only RCTs were included in the meta-analysis. Although this reduced the introduction of bias associated with nonrandomized studies, it does limit the generalizability of the findings in the real world [53].”
From Digital Interventions for Self-Management of Type 2 Diabetes Mellitus: Systematic Literature Review and Meta-Analysis (2024) · cites this paper as [53]
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- Authors
- Klonoff, D. C., Gutierrez, A., Fleming, A., & Kerr, D.
- Affiliations
- Mills Peninsula Health Services (US)
- NDA Partners LLC, Bethesda, MD, USA
- Kinexum, Harper’s Ferry, WV, USA
- Sansum Diabetes Research Institute (US)
- Corresponding author
- Kerr, David
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2019-04-03
- Volume
- 13
- Issue
- 6
- Pages
- 995-1000
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC6835188
- OpenAlex
- W2932598518
- Cited by
- 41
- References
- 28
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 8 · 2023: 5 · 2022: 5 · 2021: 8 · 2020: 6 · 2019: 2 · 2018: 1
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Sanofi
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- real-world evidence, real-world data, regulatory decision-making, diabetes mellitus, pharmaceutical products, medical devices, randomized controlled trials, social determinants of health, adverse event detection, machine learning, artificial intelligence, drug approval, post-market monitoring
- MeSH terms
- Decision Making, Diabetes Mellitus, Pharmaceutical Preparations, Equipment and Supplies, Health Policy, Humans, Randomized Controlled Trials as Topic, Device Approval, Evidence-Based Medicine
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