ArticleContemporary clinical trials communications2022
Augmenting control arms with real-world data for cancer trials: Hybrid control arm methods and considerations.
Article in Contemporary clinical trials communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Considerations for pooling real-world data as a comparator cohort to a single arm trial: a simulation study on assessment of heterogeneity.BMC medical research methodology · 2023Pooled it
- A Frequentist Approach Using Weighted Estimating Equations for Survival Analysis of Randomized Controlled Trial With External Control Arm.Biometrical journal. Biometrische Zeitschrift · 2026Article
- Statistical Guardrails for Hybrid-Controlled Trials: Robust to Confounding and Between-Study Heterogeneity.Therapeutic innovation & regulatory science · 2026Article
- External Control Augmentation Increases Estimates Precision for Finerenone plus Sodium-Glucose Cotransporter-2 Inhibitors.Kidney international reports · 2026Article
- Artificial intelligence-generated synthetic data for cancer research and clinical trials.Nature reviews. Cancer · 2026Review
- Augmented two-stage estimation for treatment switching in oncology trials: Leveraging external data for improved precision.Statistical methods in medical research · 2025Article
- Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues.CPT: pharmacometrics & systems pharmacology · 2025Review
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Hybrid controlled trials with real-world data (RWD), where the control arm is composed of both trial and real-world patients, could facilitate research when the feasibility of randomized controlled trials (RCTs) is challenging and single-arm trials would provide insufficient information. Methods: We propose a frequentist two-step borrowing method to construct hybrid control arms. We use parameters informed by a completed randomized trial in metastatic triple-negative breast cancer to simulate the operating characteristics of dynamic and static borrowing methods, highlighting key trade-offs and analytic decisions in the design of hybrid studies. Results: Simulated data were generated under varying residual-bias assumptions (no bias: HR Conclusion: By pairing high-quality external data with rigorous simulations, researchers have the potential to design hybrid controlled trials that better meet the needs of patients and drug development.
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Registered trials
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