ArticleScientific reports2024
A comparative study of clinical trial and real-world data in patients with diabetic kidney disease.
Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed.
- Considerations for the Integration of Clinical Trials and Real-World Data.Clinical pharmacology and therapeutics · 2026Review
- The unregulated majority: who ensures quality in non-submission real-world studies?Frontiers in medicine · 2026Article
- Statistical inference for heterogeneous treatment effect with right-censored data from synthesizing randomized clinical trials and real-world data.Biometrics · 2025Article
- Nephroprotective Mechanisms of SGLT2i: Beyond the Glucose-Lowering Effect.Biomedicines · 2025Review
- Treatment Outcomes Differ for Racial and Ethnic Minorities with Advanced-Stage Laryngeal Cancer: A Florida Cancer Data System Analysis.Cancer research communications · 2025Article
- The Cost-Effectiveness of Avatrombopag Versus Eltrombopag and Romiplostim in the Treatment of Patients with Immune Thrombocytopenia in the UK.Journal of market access & health policy · 2025Article
- Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues.CPT: pharmacometrics & systems pharmacology · 2025Review
- Effects of Short-Term Treatment with α-Lipoic Acid on Neuropathic Pain and Biomarkers of DNA Damage in Patients with Diabetes Mellitus.Pharmaceuticals (Basel, Switzerland) · 2024Article
- The Renoprotective Mechanisms of Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i)-A Narrative Review.International journal of molecular sciences · 2024Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A growing body of research is focusing on real-world data (RWD) to supplement or replace randomized controlled trials (RCTs). However, due to the disparities in data generation mechanisms, differences are likely and necessitate scrutiny to validate the merging of these datasets. We compared the characteristics of RCT data from 5734 diabetic kidney disease patients with corresponding RWD from electronic health records (EHRs) of 23,523 patients. Demographics, diagnoses, medications, laboratory measurements, and vital signs were analyzed using visualization, statistical comparison, and cluster analysis. RCT and RWD sets exhibited significant differences in prevalence, longitudinality, completeness, and sampling density. The cluster analysis revealed distinct patient subgroups within both RCT and RWD sets, as well as clusters containing patients from both sets. We stress the importance of validation to verify the feasibility of combining RCT and RWD, for instance, in building an external control arm. Our results highlight general differences between RCT and RWD sets, which should be considered during the planning stages of an RCT-RWD study. If they are, RWD has the potential to enrich RCT data by providing first-hand baseline data, filling in missing data or by subgrouping or matching individuals, which calls for advanced methods to mitigate the differences between datasets.
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