ReviewPharmacoepidemiology and drug safety2025
Real-World Data and Real-World Evidence in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII.
Review in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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
21 citing papers in PubMed.
- Using real-world data to predict findings of an ongoing phase IV trial: glycemic control of semaglutide versus standard of care.BMJ open diabetes research & care · 2025Trial
- Embracing Digital as a Paradigm Shift in Medical Affairs.Pharmaceutical medicine · 2026Review
- Big Data and Artificial Intelligence in Cancer Drug Discovery: Promise, Challenges, and Emerging Opportunities.Cancers · 2026Review
- Review
- Mapping the Use of Real-World Evidence Across the EU Health Technology Assessment Regulation: Methodological Considerations, Challenges, and Opportunities for Harmonization.Journal of market access & health policy · 2026Article
- Review
- Addressing Unmet Medical Needs in Drug Development: Assessment and Implications for Regulatory and Clinical Development Strategies.Journal of market access & health policy · 2026Article
- Six-Year Trends in Real-World Data Use for Post-Marketing Surveillance of New Medical Products in Japan.Clinical and translational science · 2026Review
- Linking clinical trial data with real-world data for enhanced clinical evidence generation: methodological considerations and recommendations.Frontiers in pharmacology · 2026Review
- The Precision Revolution in Hematologic Malignancies: A Decade of Transformative Immunotherapies and Targeted Agents.Journal of clinical medicine · 2025Review
- 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
- Incorporating Patient Needs and Perspectives in Additional Risk Minimization Measures and Other Pharmacovigilance Deliverables - A Framework and Implementation Roadmap.Therapeutic innovation & regulatory science · 2025Article
- Beyond Accuracy: Methodological Advances for Assessing the Clinical Impact of Infectious Disease Diagnostics.Open forum infectious diseases · 2025Article
- FRAME: Framework for Real-World Evidence Assessment to Mitigate Evidence Uncertainties for Efficacy/Effectiveness - An Evaluation of Regulatory and Health Technology Assessment Decision Making.Clinical pharmacology and therapeutics · 2025Article
- Real-World Data and Real-World Evidence in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII.Pharmacoepidemiology and drug safety · 2025Review
- Transparency in the secondary use of health data: assessing the status quo of guidance and best practices.Royal Society open science · 2025Article
- Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices.Frontiers in drug safety and regulation · 2025Article
- Evidence-based production framework for herbal medicine regulation in Indonesia.Frontiers in pharmacology · 2025Review
- Leveraging Real-World Data in Safety Signal Assessment.Therapeutic innovation & regulatory science · 2024Article
- Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data.BMC rheumatology · 2024Article
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
No grant is acknowledged in the PubMed record.
Abstract
Data from sources other than traditional randomized clinical trials are known as real-world data (RWD), and the evidence derived from the review and analysis of RWD is known as real-world evidence (RWE). RWD and RWE are used increasingly throughout the lifecycle of medicinal products to provide evidence about their effectiveness and safety. Recent regulatory guidance about RWE and approvals based on the use of RWE to demonstrate beneficial effects of products have created an urgency to develop generally accepted processes that promote trust in the evidence-generation process. A recent report from a working group of the Council for International Organizations of Medical Science (CIOMS) describes the use of RWE for decision making in the lifecycle of medical products, describes RWD and data sources, discusses key scientific considerations in the generation of RWE, and discusses ethical and governance issues related to the use of RWD. This paper provides a high-level summary of this report. More work remains to be done to globally harmonize practices and guidance for using RWD and RWE for regulatory decision making, thereby maximizing the benefits they can bring to patient care and public health.
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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.