ArticleFrontiers in medicine2021
Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model.
Article in Frontiers in medicine, 2021. 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.
- Linking Electronic Health Records for Multiple Sclerosis Research: Comparative Study of Deterministic, Probabilistic, and Machine Learning Linkage Methods.JMIR medical informatics · 2026Article
- AMCP real-world evidence standards: Overcoming barriers to using real-world evidence in US payer decision-making.Journal of managed care & specialty pharmacy · 2025Article
- Review
- A Review on Integrating Breast Cancer Clinical Data: A Unified Platform Perspective.Current treatment options in oncology · 2025Review
- Real-World Evidence BRIDGE: A Tool to Connect Protocol With Code Programming.Pharmacoepidemiology and drug safety · 2024Article
- The impact of different censoring methods for analyzing survival using real-world data with linked mortality information: a simulation study.BMC medical research methodology · 2024Article
- Formulation of a CITE metric for evaluating the clinical implications of medical studies and their originating hospitals in China.Health care science · 2024Article
- Real-world evidence for coverage determination of treatments for rare diseases.Orphanet journal of rare diseases · 2024Article
- Recording type 2 diabetes mellitus in a standardised central Saudi database: a retrospective validation study.BMJ open · 2023Article
- Overcoming personal information protection challenges involving real-world data to support public health efforts in China.Frontiers in public health · 2023Article
- Commercializing Personal Health Information: A Critical Qualitative Content Analysis of Documents Describing Proprietary Primary Care Databases in Canada.International journal of health policy and management · 2023Article
- Tactical Considerations for Designing Real-World Studies: Fit-for-Purpose Designs That Bridge Research and Practice.Pragmatic and observational research · 2023Review
- Digital child health: opportunities and obstacles. A joint statement of European Academy of Paediatrics and European Confederation of Primary Care Paediatricians.Frontiers in pediatrics · 2023Review
- Nusinersen demonstrates effectiveness in treating spinal muscular atrophy: findings from a three-year nationwide study in Korea.Frontiers in neurology · 2023Article
- Effect of Statins on All-Cause Mortality in Adults: A Systematic Review and Meta-Analysis of Propensity Score-Matched Studies.Journal of clinical medicine · 2022Review
- European Health Data Space-An Opportunity Now to Grasp the Future of Data-Driven Healthcare.Healthcare (Basel, Switzerland) · 2022Article
- Pragmatic Clinical Studies: An Emerging Clinical Research Discipline for Improving Evidence-Based Practice of Cardiovascular Diseases in Asia.Korean circulation journal · 2022Review
- The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency.Journal of pharmaceutical policy and practice · 2022Article
- Real-World and Regulatory Perspectives of Artificial Intelligence in Cardiovascular Imaging.Frontiers in cardiovascular medicine · 2022Article
- Advancing the Regulation of Traditional and Complementary Medicine Products: A Comparison of Five Regulatory Systems on Traditional Medicines with a Long History of Use.Evidence-based complementary and alternative medicine : eCAM · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the world due to their paramount role in supporting drug development and regulatory decision making. However, there is little systematic documentary analysis about how RWE was integrated for the use by the DRAs in evaluating new treatment approaches and monitoring post-market safety. This study aimed to analyze and discuss the integration of RWE into regulatory decision-making process from the perspective of DRAs. Different development strategies to develop and adopt RWE by the DRAs in the US, Europe, and China were reviewed and compared, and the challenges encountered were discussed. It was found that different strategies on development of RWE were applied by FDA, EMA, and NMPA. The extent to which RWE was adopted in China was relatively limited compared to that in the US and EU, which was highly related to the national pharmaceutical environment and development stages. A better understanding of the overall goals, inputs, activities, outputs, and outcomes in developing RWE will help inform actions to harness RWD and leverage RWE for better health care 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.