ReviewTherapeutic innovation & regulatory science2023
Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions.
Review in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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
10 citing papers in PubMed.
- Exploration of Real-World Data Sources in Latin America, Middle East and North Africa, and Asia Pacific, to Support Oncology Evidence Generation: A Targeted Literature Review and Regional Recommendations.Advances in therapy · 2026Review
- Real-World Evidence for Drug Value Assessment in China: Learning from International Experiences.Drugs - real world outcomes · 2026Article
- Cross-jurisdictional access to innovative drugs and devices: a five-year policy and practice review of the Hong Kong and Macao medicine and equipment connect in the Greater Bay Area of China.Frontiers in medicine · 2026Article
- Development of cardiovascular clinical research data warehouse and real-world research.Journal of geriatric cardiology : JGC · 2025Article
- Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: Where Are We Today?Therapeutic innovation & regulatory science · 2025Review
- Review of Challenges in Performing Real-World Evidence Studies for Nonprescription Products.Pragmatic and observational research · 2025Review
- Policy and legal perspectives on the traditional Chinese medicine varietal protection system (TCMVPS): reform or abolition?Frontiers in pharmacology · 2025Review
- Integrated Real-World Data Warehouses Across 7 Evolving Asian Health Care Systems: Scoping Review.Journal of medical Internet research · 2024Article
- Expert survey on real-world data utilization and real-world evidence generation for regulatory decision-making in drug lifecycle in Korea.Clinical and translational science · 2024Article
- Overcoming personal information protection challenges involving real-world data to support public health efforts in China.Frontiers in public health · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Real-world data (RWD) and real-world evidence (RWE) have garnered great interest for supporting drug research and development (R&D) by medical researchers and regulators in recent years. The application and development of RWD/E in drug regulatory decision-making have been vigorously promoted in China. This study seeks to provide a broad overview of how RWE has been contributing to drug regulatory decisions in China. In this paper, we review the development of RWD and RWE, summarize key elements that promote application of RWE, introduce relevant methods and guidelines, elaborate on the opportunities and challenges of RWE in regulatory decision-making in China, and put forward suggestions to promote the application of RWE in China's regulatory decision-making and to further facilitate innovative drug evaluation and regulation.
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.