Trial reportClinical pharmacology and therapeutics2020
Using Electronic Health Records to Derive Control Arms for Early Phase Single-Arm Lung Cancer Trials: Proof-of-Concept in Randomized Controlled Trials.
Trial report in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
53 citing papers in PubMed.
- Comparison of epcoritamab, lenalidomide, and rituximab versus usual care in relapsed/refractory follicular lymphoma.Oncoimmunology · 2026Trial
- Comparability of external and internal control patients for the prospective randomized HOVON-103 trial in older AML patients.British journal of haematology · 2026Trial
- External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources.American journal of respiratory and critical care medicine · 2023Trial
- Temporal Trends in Clinical Evidence of 5-Year Survival Within Electronic Health Records Among Patients With Early-Stage Colon Cancer Managed With Laparoscopy-Assisted Colectomy vs Open Colectomy.JAMA network open · 2022Trial
- Pertuzumab Plus Trastuzumab for Treatment-RefractoryJCO clinical cancer informatics · 2022Trial
- Building External Control Arms From Patient-Level Electronic Health Record Data to Replicate the Randomized IMblaze370 Control Arm in Metastatic Colorectal Cancer.JCO clinical cancer informatics · 2021Trial
- Constructing an External Control Arm Using the French REALYSA Cohort to Replicate Outcomes of a Randomized Trial Arm in Advanced Hodgkin Lymphoma.Clinical pharmacology and therapeutics · 2026Article
- Real-World Evidence of Treatment Patterns, Time to Real-World Progression, and Overall Survival of Patients With Testicular Germ Cell Tumors Receiving Palliative Chemotherapy in the United States.Cancer medicine · 2026Article
- Examining the Reliability of Model-Based Meta-Analysis (MBMA) Outcomes: A Simulation Study.CPT: pharmacometrics & systems pharmacology · 2026Article
- Sieving for gold: external comparator studies to prioritize drugs for late-stage clinical trial.Journal of comparative effectiveness research · 2026Review
- Biomarkers for predicting immunotherapy response and resistance in glioblastoma.Frontiers in immunology · 2026Review
- An External Control Arm for the Oral Factor XIa Inhibitor Asundexian Phase 2 Trial in Atrial Fibrillation (PACIFIC-AF) Using Electronic Health Records.Cardiology and therapy · 2025Article
- Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues.CPT: pharmacometrics & systems pharmacology · 2025Review
- Quantitative Bias Analysis for Single-Arm Trials With External Control Arms.JAMA network open · 2025Article
- Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations.Drug safety · 2024Article
- A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials.Therapeutic innovation & regulatory science · 2024Review
- Incorporating external controls in the design of randomized clinical trials: a case study in solid tumors.BMC medical research methodology · 2024Article
- Article
- Clinical Research Informatics: a Decade-in-Review.Yearbook of medical informatics · 2024Review
- Article
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Oncology drug development increasingly relies on single-arm clinical trials. External controls (ECs) derived from electronic health record (EHR) databases may provide additional context. Patients from a US-based oncology EHR database were aligned with patients from randomized controlled trials (RCTs) and trial-specific eligibility criteria were applied to the EHR dataset. Overall survival (OS) in the EC-derived control arm was compared with OS in the RCT experimental arm. The primary outcome was OS, defined as time from randomization or treatment initiation (EHR) to death. Cox regression models were used to obtain effect estimates using EHR data. EC-derived hazard ratio estimates aligned closely with those from the corresponding RCT with one exception. Comparing log HRs among all RCT and EC results gave a Pearson correlation coefficient of 0.86. Properly selected control arms from contemporaneous EHR data could be used to put single-arm trials of OS in advanced non-small cell lung cancer into context.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.