Trial reportJournal of the National Cancer Institute2023
Target trial emulation to assess real-world efficacy in the Epidemiological Strategy and Medical Economics metastatic breast cancer cohort.
Trial report in Journal of the National Cancer Institute, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03275311 (Epidemiological Strategy and Medical Economic), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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.
Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Database: Evolution of the Therapeutic Care in Metastatic Breast Cancer Across the French Comprehensive Cancer Centers From 2008
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.
- Concordance between target trial emulation and randomised controlled trials: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2026Pooled it
- Impact of concomitant proton pump inhibitors in patients treated for advanced or metastatic NSCLC: a target trial emulation protocol.ESMO real world data and digital oncology · 2026Article
- Article
- Evaluating bias in target trial emulation for heart failure across statistical and deep learning methods.Nature communications · 2026Article
- Identifying the Initiation of a New Line of Therapy for Metastatic Lung, Breast, and Colorectal Cancer in Real-World Data: A Scoping Review.Pharmacoepidemiology and drug safety · 2026Article
- Design and Implementation of Observational Studies Emulating a Target Trial.JAMA network open · 2026Article
- Comparative Effectiveness of Laparoscopic versus Open Colectomy on 5-Year Overall Survival in Non-Metastatic Colon Cancer: A Target Trial Emulation Study Using Retrospective Cohort Data from a Cancer Registry.Clinical epidemiology · 2026Article
- Enhancing confidence in complex health technology assessments by using real-world evidence: highlighting existing strategies for effective drug evaluation.BMC medical research methodology · 2025Review
- TriNetX and Real-World Evidence: A Critical Review of Its Strengths, Limitations, and Bias Considerations in Clinical Research.ASIDE internal medicine · 2025Article
- Comparative effectiveness of laparoscopic versus open colectomy in colon cancer patients: a study protocol for emulating a target trial using cancer registry data.Journal of cancer research and clinical oncology · 2025Article
- Metronomic chemotherapy of paclitaxel plus cisplatin in patients with metastatic breast cancer: a target trial emulation study.Therapeutic advances in medical oncology · 2025Article
- Target trial emulation in oncology: current use and future directions.Military Medical Research · 2025Article
- When to stop immunotherapy for advanced melanoma: the emulated target trials.EClinicalMedicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundReal-world data studies usually consider biases related to measured confounders. We emulate a target trial implementing study design principles of randomized trials to observational studies; controlling biases related to selection, especially immortal time; and measured confounders.
methodsThis comprehensive analysis emulating a randomized clinical trial compared overall survival in patients with HER2-negative metastatic breast cancer (MBC), receiving as first-line treatment, either paclitaxel alone or combined to bevacizumab. We used data from 5538 patients extracted from the Epidemiological Strategy and Medical Economics-MBC cohort to emulate a target trial using advanced statistical adjustment techniques including stabilized inverse-probability weighting and G-computation, dealing with missing data with multiple imputation, and performing a quantitative bias analysis for residual bias due to unmeasured confounders.
resultsEmulation led to 3211 eligible patients, and overall survival estimates achieved with advanced statistical methods favored the combination therapy. Real-world effect sizes were close to that assessed in the existing E2100 randomized clinical trial (hazard ratio = 0.88, P = .16), but the increased sample size allowed to achieve a higher level of precision in real-world estimates (ie, reduced confidence intervals). Quantitative bias analysis confirmed the robustness of the results with respect to potential unmeasured confounding.
conclusionTarget trial emulation with advanced statistical adjustment techniques is a promising approach to investigate long-term impact of innovative therapies in the French Epidemiological Strategy and Medical Economics-MBC cohort while minimizing biases and provides opportunities for comparative efficacy through the synthetic control arms provided. DATABASE REGISTRATION: clinicaltrials.gov Identifier NCT03275311.
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What Socratic holds
Registered trials
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 Socratic graph.