ReviewClinical pharmacology and therapeutics2019
Using Real-World Data to Extrapolate Evidence From Randomized Controlled Trials.
Review in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis 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
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Advancing the role of real-world evidence in comparative effectiveness research.Journal of comparative effectiveness research · 2024Pooled it
- The replicability of real-world evidence for the surgical treatment of proximal humeral fractures in older patients evaluated using sceptical p-value.Scientific reports · 2026Observational
- Editorial: Utilizing real-world evidence for better endocrine health management.Frontiers in endocrinology · 2026Article
- Review
- Effectiveness and safety of upadacitinib in a real-world cohort of patients with Crohn's disease in the UK: a multicentre retrospective cohort study.BMJ open gastroenterology · 2025Article
- Article
- Channeling of New Neuropsychiatric Drugs-Impact on Safety and Effectiveness Studies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023Article
- Article
- Real-World Outcomes of Systemic Therapy in Japanese Patients with Cancer (Tokushukai REAl-World Data Project: TREAD): Study Protocol for a Nationwide Cohort Study.Healthcare (Basel, Switzerland) · 2022Article
- Direct Oral Anticoagulants (DOACs) are Non-Inferior to Vitamin K Antagonists for Patients Undergoing Transcatheter Aortic Valve Replacement with Indications of Anticoagulation.Reviews in cardiovascular medicine · 2022Article
- Article
- Buprenorphine Treatment for Opioid Use Disorder in Community-Based Settings: Outcome Related to Intensity of Services and Urine Drug Test Results.The American journal on addictions · 2020Article
- Current challenges for assessing the long-term clinical benefit of cancer immunotherapy: a multi-stakeholder perspective.Journal for immunotherapy of cancer · 2020Article
- The New Paradigms in Clinical Research: From Early Access Programs to the Novel Therapeutic Approaches for Unmet Medical Needs.Frontiers in pharmacology · 2019Review
- Target Aggregate Data Adjustment Method for Transportability Analysis Utilizing Summary-Level Data From the Target Population.Pharmaceutical statisticsArticle
- Real-world efficacy and safety of Tenecteplase versus Alteplase in acute ischemic stroke: a propensity score-matched analysis.Frontiers in neurologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
Randomized controlled trials (RCTs) provide evidence for regulatory agencies, shape clinical practice, influence formulary decisions, and have important implications for patients. However, many patient groups that are major consumers of drugs are under-represented in randomized trials. We review three methods to extrapolate evidence from trial participants to different target populations following market approval and discuss how these could be implemented in practice to support regulatory and health technology assessment decisions. Although these methods are not a substitute for less restrictive pre-approval RCTs or rigorous observational studies when sufficient data are available in the post-approval setting, they can help to fill the evidence gap that exists in the early marketing period. Early evidence using real-world data and methods for extrapolating evidence should be reported with clear explanation of assumptions and limitations especially when used to support regulatory and health technology assessment decisions.
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.