Worldwide Trends in Registering Real-World Studies at ClinicalTrials.gov: A Cross-Sectional Analysis

Abstract

Yuanxiao Li,1,* Ying Tian,2,* Shufen Pei,3 Baoyuan Xie,2 Xiaonan Xu,1 Bin Wang4 1Department of Pediatric Gastroenterology, Lanzhou University Second Hospital, Lanzhou, People’s Republic of China; 2Department of Clinical Medicine, Lanzhou University Second Hospital, Lanzhou, People’s Republic of China; 3Department of Clinical Medicine, North Sichuan Medical College, Nanchong, People’s Republic of China; 4Department of Infectious Diseases, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People’s Republic of China*These authors contributed equally to this workCorrespondence: Bin Wang, 88 Jie Fang Lu, Shangcheng District, Hangzhou, Zhejiang, 310009, People’s Republic of China, Email [email protected]: The purpose of this study was to characterize real-world studies (RWSs) registered at ClinicalTrials.gov to help investigators better conduct relevant research in clinical practice.Methods: A retrospective analysis of 944 studies was performed on February 28, 2023.Results: A total of 944 studies were included. The included studies involved a total of 48 countries. China was the leading country in terms of the total number of registered studies (37.9%, 358), followed by the United States (19.7%, 186). Regarding intervention type, 42.4% (400) of the studies involved drugs, and only 9.1% (86) of the studies involved devices. Only 8.5% (80) of the studies mentioned both the detailed study design type and data source in the “Brief Summary”. A total of 49.4% (466) of studies had a sample size of 500 participants and above. Overall, 63% (595) of the studies were single-center studies. A total of 213 conditions were covered in the included studies. One-third of the studies (32.7%, 309) involved neoplasms (or tumors). China and the United States were very different regarding the study of different conditions.Conclusion: Although the pandemic has provided new opportunities for RWSs, the rigor of scientific research still needs to be emphasized. Special attention needs to be given to the correct and comprehensive description of the study design in the Brief Summary of registered studies, thereby promoting communication and understanding. In addition, deficiencies in ClinicalTrials.gov registration data remain prominent.Keywords: real-world data, real-world evidence, real-world study, study design, ClinicalTrials.gov

Keywords

• real-world data
• real-world evidence
• real-world study
• study design
• clinicaltrials.gov