ArticleClinical epidemiology2022
Oncology Drug Effectiveness from Electronic Health Record Data Calibrated Against RCT Evidence: The PARSIFAL Trial Emulation.
Article in Clinical epidemiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.
- Concordance between target trial emulation and randomised controlled trials: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2026Pooled it
- Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review.JAMA network open · 2023Pooled it
- Target trial emulation studies in oncology: a comprehensive analysis.The oncologist · 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
- Missingness in Eligibility Criteria for Target Trial Emulation in EHR With Survival Outcomes.Statistics in medicine · 2026Article
- Assessing the replicability of RCTs in RWE emulations.BMC medical research methodology · 2025Article
- Real-world evidence in the reassessment of oncology therapies: payer perceptions from five countries.Future oncology (London, England) · 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
Abstract
Background: The use of electronic health records (EHR) data to assess drug effectiveness in clinical oncology practice is of great interest to regulators, clinicians, and payers. However, the utility of EHR data in clinical effectiveness studies may be limited by missing data, unmeasured confounding, and imperfect outcome surveillance. This study sought to emulate and compare the results of a randomized controlled trial investigating the efficacy of palbociclib with fulvestrant vs letrozole in advanced breast cancer. Methods: This was a cohort study using longitudinal EHR data derived from outpatient oncology practices in the United States. Eligibility criteria from the PARSIFAL trial were emulated as closely as possible. Patients were included if they had hormone-positive, human epidermal growth factor receptor - 2 (HER-2) negative metastatic breast cancer and had no record of prior treatment for metastatic disease. Patients initiating first-line treatment with palbociclib and fulvestrant following their first record of metastasis were compared to those initiating palbociclib and letrozole on the same day. Treatments were ascertained by oncology medication ordering records in the data source. The primary outcome was death as recorded in the oncologists' EHR systems. Results: There were 1886 eligible women in the study cohort. Although the 3-year survival was meaningfully lower in clinical practice (59%) compared to the randomized trial (78%), the relative effect size was a hazard ratio (HR) of 1.07 (95% CI: 0.86-1.35), similar to the randomized trial (HR = 1.00; 95% CI: 0.68-1.48). Conclusion: Despite common challenges encountered in EHR-based studies, it is possible to achieve similar conclusions to emulated randomized trials with the application of analytic approaches that address missing data, confounding, and selection bias. This is a promising finding in light of other emulations and ongoing efforts to improve data from clinical practice and causal analytics.
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What OpenQuestion 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 OpenQuestion graph.