ReviewClinical pharmacology and therapeutics2020
Examining the Use of Real-World Evidence in the Regulatory Process.
Review in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 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
84 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effectiveness of Single-Tablet Combination Therapy in Improving Adherence and Persistence and the Relation to Clinical and Economic Outcomes.Journal of health economics and outcomes research · 2024Pooled it
- Augmenting randomized clinical trial data with historical control data: Precision medicine applications.Journal of the National Cancer Institute · 2023Trial
- Temporal Trends in Clinical Evidence of 5-Year Survival Within Electronic Health Records Among Patients With Early-Stage Colon Cancer Managed With Laparoscopy-Assisted Colectomy vs Open Colectomy.JAMA network open · 2022Trial
- A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement.International journal of spine surgery · 2026Article
- Maximizing the impact of real-world evidence on cancer treatment: what do we need to achieve it?Journal of comparative effectiveness research · 2026Review
- Linking Electronic Health Records for Multiple Sclerosis Research: Comparative Study of Deterministic, Probabilistic, and Machine Learning Linkage Methods.JMIR medical informatics · 2026Article
- Survival of Intravenous Edaravone-Treated Patients With ALS: Evidence From Administrative Claims Analyses.Muscle & nerve · 2026Article
- Review
- Advancing global health access through market shaping: Cases and learnings.PLOS global public health · 2026Review
- AI in Neurology: Everything, Everywhere, All at Once Part 3: Surveillance, Synthesis, Simulation, and Systems.Annals of neurology · 2025Review
- Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real-World Data Sources for Fit-for-Purpose Studies.Clinical pharmacology and therapeutics · 2025Article
- Real-world management and outcomes of immune-related adverse events in German cancer care: A multicenter analysis using the SERIO registry.The oncologist · 2025Article
- A Podcast on Real-World Evidence with Avelumab First-Line Maintenance and Treatment Sequencing in Locally Advanced or Metastatic Urothelial Carcinoma.Targeted oncology · 2025Article
- Evidence available and used by the Food and Drug Administration for the approval of orphan and nonorphan drugs.Health affairs scholar · 2025Article
- Nonprescription Magnesium Supplement Use and Risk of Heart Failure in Patients With Diabetes: A Target Trial Emulation.Journal of the American Heart Association · 2025Article
- Transparency in the secondary use of health data: assessing the status quo of guidance and best practices.Royal Society open science · 2025Article
- Use of real-world evidence in the Medicare Drug Price Negotiation Program: A checklist for the Centers for Medicare and Medicaid Services and manufacturers.Health affairs scholar · 2025Article
- The EU project Real4Reg: unlocking real-world data with AI.Health research policy and systems · 2025Article
- Longer disease progression milestone-free time in people with amyotrophic lateral sclerosis treated versus not treated with intravenous edaravone: results from an administrative claims analysis.Journal of comparative effectiveness research · 2025Observational
- Tempered enthusiasm by interviewed experts for synthetic data and ELSI checklists for AI in medicine.AI and ethics · 2025Article
24 more citing papers are in PubMed but not listed here.
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
The 21st Century Cures Act passed by the United States Congress mandates the US Food and Drug Administration to develop guidance to evaluate the use of real-world evidence (RWE) to support the regulatory process. RWE has generated important medical discoveries, especially in areas where traditional clinical trials would be unethical or infeasible. However, RWE suffers from several issues that hinder its ability to provide proof of treatment efficacy at a level comparable to randomized controlled trials. In this review article, we summarized the advantages and limitations of RWE, identified the key opportunities for RWE, and pointed the way forward to maximize the potential of RWE for regulatory purposes.
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.