ReviewClinical pharmacology and therapeutics2025
Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence.
Review in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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
10 citing papers in PubMed.
- Case Study on the Use of Real-World Evidence in a Feasibility Assessment of a Randomized Controlled Trial Design to Support the Fulfillment of Pediatric Requirements with the FDA and EMA.Therapeutic innovation & regulatory science · 2026Article
- Exploration of Real-World Data Sources in Latin America, Middle East and North Africa, and Asia Pacific, to Support Oncology Evidence Generation: A Targeted Literature Review and Regional Recommendations.Advances in therapy · 2026Review
- Pathways to Real World Evidence From the Real World of School-Based Physical Fitness Testing (SB-PFT).Learning health systems · 2026Article
- Assessing Research Impact With Bibliometrics and Altmetrics: The Case of the Canadian Network for Observational Drug Effect Studies (CNODES).Pharmacoepidemiology and drug safety · 2026Article
- Real-world evidence in metabolic dysfunction-associated steatotic liver disease (MASLD): insights, challenges, and future directions.The Lancet regional health. Europe · 2026Review
- From system building to global engagement: Current significance of and future directions for rare disease research in China.Intractable & rare diseases research · 2026Article
- Six-Year Trends in Real-World Data Use for Post-Marketing Surveillance of New Medical Products in Japan.Clinical and translational science · 2026Review
- Real-world evidence from Germany: representativeness analysis and mortality endpoint validation in electronic health record-derived oncology cohorts.BMC cancer · 2026Article
- Evolving Real-World Data and Evidence Use for New Drugs and Regenerative Medical Products Approvals in Japan-An Analysis of the 6-Year Trend.Clinical pharmacology and therapeutics · 2025Review
- Real-World Evidence Acceptability and Use in Breast Cancer Treatment Decision-Making in the United States: Call-to-Action from a Multidisciplinary Think Tank.Advances in therapy · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A compilation of factors over the past decade-including the availability of increasingly large and rich healthcare datasets, advanced technologies to extract unstructured information from health records and digital sources, advancement of principled study design and analytic methods to emulate clinical trials, and frameworks to support transparent study conduct-has ushered in a new era of real-world evidence (RWE). This review article describes the evolution of the RWE era, including pharmacoepidemiologic methods designed to support causal inferences regarding treatment effects, the role of regulators and other health authorities in establishing distributed real-world data networks enabling analytics at scale, and the many global guidance documents on principled methods of producing RWE. This article also highlights the growing opportunity for RWE to support decision making by regulators, health technology assessment groups, clinicians, patients, and other stakeholders and provides examples of influential RWE studies. RWE holds promise to address important questions that clinical trials typically do not answer about treatment benefits and risks, and to ultimately impact public health by helping to guide decision making across the healthcare ecosystem.
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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.