ArticleDrugs - real world outcomes2026
Feasibility of Reconstructing Survival Outcomes from Unstructured Electronic Medical Records under Japan's Next-Generation Medical Infrastructure Act: A Historical Cohort Study of Atezolizumab in Non-small Cell Lung Cancer.
Article in Drugs - real world outcomes, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
BACKGROUND AND
objectiveAs the use of real-world evidence (RWE) expands, evaluating whether Japanese real-world data (RWD) can reproduce clinical trial findings is crucial. This study aimed to determine whether pseudonymized medical information collected under the Next-Generation Medical Infrastructure Act could reconstruct a patient cohort comparable to the Japanese subgroup of the OAK trial and to evaluate progression-free survival (PFS) and overall survival (OS) in patients with non-small cell lung cancer (NSCLC) treated with atezolizumab.
methodsWe conducted a historical cohort study using the Millennium Medical Record database. Medical information collected between 1 October 2015, and 31 October 2022 was utilized, and the study itself was conducted from September 2023 to February 2024. Patients treated with atezolizumab for NSCLC were identified, and eligibility criteria from the OAK trial were applied. Effectiveness outcomes were extracted from unstructured electronic medical record text by trained abstractors through manual review of the medical records, ensuring robustness of the assessments.
resultsA total of 75 patients were analyzed. The median PFS was 3.5 months (95% CI 2.3-8.9), comparable to the 4.2 months (95% CI 2.8-4.4) reported in the OAK trial's Japanese subgroup. Subgroup analyses showed numerical distance, with shorter PFS in patients with advanced stage and poor performance status, consistent with clinical expectations. Median OS was not reached, likely due to censoring from untracked hospital transfers.
conclusionsThis study demonstrated the feasibility of extracting PFS from unstructured text in RWD, yielding results comparable to clinical trials. While OS estimation faced challenges due to tracking limitations, future integration with the National Database under the revised law is expected to enhance accuracy, paving the way for using this infrastructure to generate external control arms.
Identifiers
42489799What 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.