ReviewFrontiers in medicine2023
Real-world evidence for regulatory decision-making: updated guidance from around the world.
Review in Frontiers in medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses 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
23 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Translation readiness of model-based synthetic tabular data in healthcare: a systematic review and governance audit.Journal of the American Medical Informatics Association : JAMIA · 2026Pooled it
- Effectiveness and safety of therapies for patients with opioid use disorder: a systematic review and network meta-analysis.Journal of comparative effectiveness research · 2026Pooled it
- Multicenter Evaluation of Ceftazidime/Avibactam in Pediatric Patients Across the United States: Real-World Insights into the Management of Drug-Resistant Gram-Negative Infections.Open forum infectious diseases · 2026Trial
- Considerations for the Integration of Clinical Trials and Real-World Data.Clinical pharmacology and therapeutics · 2026Review
- Assessment of real-world evidence research competencies in federated research networks: a maternal health fellowship program evaluation.JAMIA open · 2026Article
- Real-World Evidence from a Large German Outpatient Database for Oncology Research: A Narrative Review.Cancers · 2026Review
- 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
- Introducing an Expanded Value Framework in Health Technology Assessment of Vaccines.Journal of market access & health policy · 2026Article
- Legal Basis and Regulatory Requirements for Utilizing Real-World Evidence in Medical Product Regulatory Decision-Making.Pharmacoepidemiology and drug safety · 2026Article
- Advancing real-world evidence harmonization: lessons from the UK, EMA and global policy frameworks.Journal of comparative effectiveness research · 2026Review
- Evaluating the Effectiveness of 2024-2025 Seasonal mRNA-1273 Vaccination Against COVID-19-Related Hospitalizations and Medically Attended COVID-19 Among Adults Aged ≥ 18 years in the United States: An Observational Matched Cohort Study.Infectious diseases and therapy · 2026Article
- Best Practices and Gaps in Current Regulatory and Health Technology Assessment Real-World Evidence Policies for Medicines and Medical Devices: Current State of Play and Next Steps.Clinical and translational science · 2026Review
- 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 Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Real-World Evidence on the Use of Traditional Korean Medicine in Managing Intervertebral Disc Disease.Healthcare (Basel, Switzerland) · 2025Article
- Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning.Clinical and translational science · 2025Review
- Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence.Clinical pharmacology and therapeutics · 2025Review
- Article
- Evaluating biosimilars: safety, efficacy, and regulatory considerations in clinical studies.International journal of clinical pharmacy · 2025Review
- Mapping the therapeutic versatility of WHO essential medicines: a systematic analysis of off-label indications.Therapeutic advances in drug safety · 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
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Leveraging the value of real-world evidence (RWE) to make informed regulatory decisions in the field of health care continues to gain momentum. Improving clinical evidence generation by evaluating the outcomes and patient experiences at the point-of-care would help achieve the ultimate aim of ensuring that effective and safe treatments are rapidly approved for patient use. In our previous publication, we assessed the global regulatory landscape with respect to RWE and provided a review of the regional availability of frameworks and guidance through May 2021 on the basis of 3 key regulatory elements: regulatory RWE frameworks, data quality guidance, and study methods guidance. In the current review, we have updated and elaborated upon recent developments in the regulatory RWE environment from a regional perspective under the same 3 regulatory elements stated above. In addition, we have also included a new category on procedural guidance. The review also discusses the perceived gaps and potential opportunities for future development and harmonization in this field to support framework establishment in regions without pre-existing RWE policies. Additionally, the article reviews current developments of health technology assessment (HTA) bodies pertaining to RWE and discusses the status of evidentiary alignment among regulators and HTA agencies.
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.