Advancing Real World Evidence: Comparative Insights into Global Practices and China's Strategic Progress
Author(s)
Junli Zhu, MPH1, Weihong Yuan, PhD2, Yuan Wang, PhD1, Xiaoting Shi, PhD1, Shuo Yang, PhD1, Zheng Yin, PhD1, Shuangshuang Cai, Master2, Hongwei Yun, Bachelor2, Huilin Liang, Master2.
1Real World Solutions, IQVIA, Shanghai, China, 2Hainan Lecheng Institute of Real World Study, Qionghai, China.
1Real World Solutions, IQVIA, Shanghai, China, 2Hainan Lecheng Institute of Real World Study, Qionghai, China.
Presentation Documents
OBJECTIVES: Real World Evidence (RWE) is reshaping healthcare globally, leveraging real world data (RWD) to inform decision-making. This study evaluates RWE advancement in multiple countries/markets from different perspectives (e.g., regulatory framework, data accessibility, academic contribution, and patient benefits) with a focus on China.
METHODS: The study combines comparative policy analysis, literature review, and case study approaches. By examining 36,601 Chinese publications and 102,825 English publications from 2014 to 2023, it compares the policy frameworks and developmental trends of RWS across the US, the EU, and China. Leveraging insights from literature and cases, the report comprehensively evaluates the global RWS regulatory systems, data quality, data access, and academic outputs.
RESULTS: The study identifies the US and EU have more mature systems for RWE, emphasizing standardization, privacy, and interoperability. Comparatively, China has rapidly developed its RWE capabilities in recent years, supported by national initiatives like the Boao Lecheng pilot zone and regulatory frameworks for RWD in drug and device evaluation. While its infrastructure has expanded significantly, challenges remain in database openness, quality standards, and data verification in China. From 2014 to 2023, global RWE publications increased significantly, with China also demonstrating robust growth but lagging in high-quality studies. Disease area varied for RWE publications, with oncology, cardiovascular disease, and rare diseases being key focus. Overall, China RWE development prioritizes addressing urgent medical needs but requires further integration into global standards.
CONCLUSIONS: China's rapid advancement in RWE reflects strong policy support and substantial research potential. However, to match global benchmarks, enhancing data governance, adopting international standards, and promoting database interoperability are crucial. Strategic investments in quality assurance and pilot initiatives can position China as one of the leaders in global RWE, contributing to evidence-based healthcare innovation and improved patient outcomes.
METHODS: The study combines comparative policy analysis, literature review, and case study approaches. By examining 36,601 Chinese publications and 102,825 English publications from 2014 to 2023, it compares the policy frameworks and developmental trends of RWS across the US, the EU, and China. Leveraging insights from literature and cases, the report comprehensively evaluates the global RWS regulatory systems, data quality, data access, and academic outputs.
RESULTS: The study identifies the US and EU have more mature systems for RWE, emphasizing standardization, privacy, and interoperability. Comparatively, China has rapidly developed its RWE capabilities in recent years, supported by national initiatives like the Boao Lecheng pilot zone and regulatory frameworks for RWD in drug and device evaluation. While its infrastructure has expanded significantly, challenges remain in database openness, quality standards, and data verification in China. From 2014 to 2023, global RWE publications increased significantly, with China also demonstrating robust growth but lagging in high-quality studies. Disease area varied for RWE publications, with oncology, cardiovascular disease, and rare diseases being key focus. Overall, China RWE development prioritizes addressing urgent medical needs but requires further integration into global standards.
CONCLUSIONS: China's rapid advancement in RWE reflects strong policy support and substantial research potential. However, to match global benchmarks, enhancing data governance, adopting international standards, and promoting database interoperability are crucial. Strategic investments in quality assurance and pilot initiatives can position China as one of the leaders in global RWE, contributing to evidence-based healthcare innovation and improved patient outcomes.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR30
Topic
Health Policy & Regulatory
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways
Disease
No Additional Disease & Conditions/Specialized Treatment Areas