ArticleJournal of the American Medical Informatics Association : JAMIA2021
Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review.
Article in Journal of the American Medical Informatics Association : JAMIA, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 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
36 citing papers in PubMed.
- Endpoint assessment via routinely collected data generates estimates comparable to randomized controlled trial data: analysis of a cluster-randomized trial on fall injury prevention.Journal of clinical epidemiology · 2025Trial
- Trial
- Real-World Estimates of HIV Incidence From Sexual Health Clinic EMRs: Feasibility, Limitations, and Implications for Surveillance.Journal of acquired immune deficiency syndromes (1999) · 2026Article
- Integrating real-world data with gold-standard longitudinal clinical and genomic data to advance precision medicine for the Alzheimer's Disease Research Center Program and beyond: a proof-of-concept data platform.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Factors associated with enrollment in a randomized clinical trial of docosahexaenoic supplementation in toddlers born preterm.Clinical trials (London, England) · 2026Article
- The association between cardiometabolic index and hypertension-diabetes comorbidity among adults aged 45 and older: evidence from two national databases.BMC endocrine disorders · 2026Article
- Linking clinical trial data with real-world data for enhanced clinical evidence generation: methodological considerations and recommendations.Frontiers in pharmacology · 2026Review
- Large Language Models for Automating Clinical Trial Criteria Conversion to Observational Medical Outcomes Partnership Common Data Model Queries: Validation and Evaluation Study.JMIR medical informatics · 2025Article
- Reusing data from HL7 CDA-based shared EHR systems for clinical trial conduct: a method for analyzing feasibility.BMC medical informatics and decision making · 2025Article
- Linkage of Clinical Trial Data to Routinely Collected Data Sources: A Scoping Review.JAMA network open · 2025Article
- Temporal Ensemble Logic for Integrative Representation of the Entirety of Clinical Trials.LIPIcs : Leibniz international proceedings in informatics · 2025Article
- Article
- The use of linked administrative data in Australian randomised controlled trials: A scoping review.Clinical trials (London, England) · 2024Article
- Article
- Article
- A comparative study of clinical trial and real-world data in patients with diabetic kidney disease.Scientific reports · 2024Article
- Randomized-controlled trials are methodologically inappropriate in adolescent transgender healthcare.International journal of transgender health · 2024Review
- The Roles of Electronic Health Records for Clinical Trials in Low- and Middle-Income Countries: Scoping Review.JMIR medical informatics · 2023Article
- The Stanford Medicine data science ecosystem for clinical and translational research.JAMIA open · 2023Article
- Integrated Real-World Study Databases in 3 Diverse Asian Health Care Systems in Taiwan, India, and Thailand: Scoping Review.Journal of medical Internet research · 2023Article
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
Abstract
objectiveReal-world data (RWD), defined as routinely collected healthcare data, can be a potential catalyst for addressing challenges faced in clinical trials. We performed a scoping review of database-specific RWD applications within clinical trial contexts, synthesizing prominent uses and themes. MATERIALS AND
methodsQuerying 3 biomedical literature databases, research articles using electronic health records, administrative claims databases, or clinical registries either within a clinical trial or in tandem with methodology related to clinical trials were included. Articles were required to use at least 1 US RWD source. All abstract screening, full-text screening, and data extraction was performed by 1 reviewer. Two reviewers independently verified all decisions.
resultsOf 2020 screened articles, 89 qualified: 59 articles used electronic health records, 29 used administrative claims, and 26 used registries. Our synthesis was driven by the general life cycle of a clinical trial, culminating into 3 major themes: trial process tasks (51 articles); dissemination strategies (6); and generalizability assessments (34). Despite a diverse set of diseases studied, <10% of trials using RWD for trial process tasks evaluated medications or procedures (5/51). All articles highlighted data-related challenges, such as missing values. DISCUSSION: Database-specific RWD have been occasionally leveraged for various clinical trial tasks. We observed underuse of RWD within conducted medication or procedure trials, though it is subject to the confounder of implicit report of RWD use.
conclusionEnhanced incorporation of RWD should be further explored for medication or procedure trials, including better understanding of how to handle related data quality issues to facilitate RWD use.
Indexed as
Identifiers
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.