ArticleJournal of medical Internet research2023
Data Challenges for Externally Controlled Trials: Viewpoint.
Article in Journal of medical Internet research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed.
- Considerations for the Integration of Clinical Trials and Real-World Data.Clinical pharmacology and therapeutics · 2026Review
- Design, Conduct, and Analysis of Externally Controlled Trials.JAMA network open · 2025Article
- Possible selection bias in register-based obesity studies.European journal of epidemiology · 2025Article
- The Potential to Leverage Real-World Data for Pediatric Clinical Trials: A Proof-of-Concept Study.Journal of medical Internet research · 2025Article
- Informative censoring in externally controlled clinical trials: a potential source of bias.ESMO open · 2025Article
- Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study.BMC medical research methodology · 2024Article
- Examining external control arms in oncology: A scoping review of applications to date.Cancer medicine · 2024Article
- Augmenting external control arms using Bayesian borrowing: a case study in first-line non-small cell lung cancer.Journal of comparative effectiveness research · 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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The preferred evidence of a large randomized controlled trial is difficult to adopt in scenarios, such as rare conditions or clinical subgroups with high unmet needs, and evidence from external sources, including real-world data, is being increasingly considered by decision makers. Real-world data originate from many sources, and identifying suitable real-world data that can be used to contextualize a single-arm trial, as an external control arm, has several challenges. In this viewpoint article, we provide an overview of the technical challenges raised by regulatory and health reimbursement agencies when evaluating comparative efficacy, such as identification, outcome, and time selection challenges. By breaking down these challenges, we provide practical solutions for researchers to consider through the approaches of detailed planning, collection, and record linkage to analyze external data for comparative efficacy.
Indexed as
Identifiers
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.