(B-074) From Catalogue to Clarity: Characterizing Chinese Data Sources for Post-Authorization Real-World Studies

Background: Many data sources (DS) have emerged in response to the growing demand for real-world evidence to support healthcare decision-making in China. However, publicly available information about these DS is limited. Existing Chinese real-world DS have not been systematically evaluated for their suitability for use in studies investigating the utilization, safety, and effectiveness of medicines on publicly available platform.

Objectives: To identify, describe, and assess the reporting of Chinese DS in post-authorization real-world studies registered in Heads of Medicines Agencies–European Medicines Agency (HMA-EMA) Catalogue between 2014 and 2024.

Methods: The HMA-EMA Catalogue was screened to identify ongoing or completed studies including at least one DS with participants from mainland China. Full-texts (e.g., protocol and report) were reviewed to extract characteristics of Chinese DS, which were summarized and evaluated for reporting quality across nine dimensions in accordance with the latest scientific recommendations for reporting real-world DS: organization, data originator, prompt, inclusion in the population, content, data dictionary, time span, healthcare system and culture, and data quality (Gini 2024).

Results: Of 4,188 records listed, 45 studies were eligible based on title/context screening. After full-text review, 25 studies were excluded for lacking Chinese DS descriptions, 2 were conducted outside mainland China, and 3 had inadequate designs (e.g., reviews, meta-analysis). Ultimately, 15 studies were included, spanning therapeutic areas like infectious diseases, cancer, hematology, endocrinology, pulmonology, and medical devices. All studies were sponsored by biopharma companies, with 12 utilizing research-specific DS (e.g., medical records, disease registries) and 3 relying on regional-level databases from administrative healthcare registrations and electronic medical records. Reporting quality varied: 6 studies reported 4 dimensions (organization, data originator, prompt, content), 6 reported 5-6 dimensions (+ data dictionary, time span), and only 3 fully reported all 9 dimensions.

Conclusions: Among over 4,000 records in the HMA-EMA Catalogue, only 15 full-text studies (0.4%) included a DS recruiting participants from mainland China. Notably, the description of Chinese DS was limited, as 80% of studies reported only 4-6 of 9 recommended dimensions to characterize DS. Recognizing this review only searched within the catalogue, a better understanding and comprehensive reporting of Chinese DS in post-authorization real-world studies are essential to generate robust evidence for regulatory purposes and enhance transparency and safety of medical products authorized in China.