Analysis of the status of real world studies based on the Chinese clinical trial registry_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Shichun ¹ , LI Hongyan ² , MA Wenhao ¹ , YAN Siyu ¹ , HUANG Qiao ¹ ,  SHANG Hongcai ³ ,  JIN Yinghui ¹

1. Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan 430071, P. R. China;
2. Department of Pharmacy, Yantai Yuhuangding Hospital, Yantai 264000, P. R. China;
3. Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100000, P. R. China;

Corresponding author：

SHANG Hongcai, Email: shanghongcai@bucm.edu.cn; JIN Yinghui, Email: jinyinghui0301@163.com

Keywords：

Real world study; Chinese clinical trial register; Clinical trial register

DOI：

10.7507/1672-2531.202207081

Video：

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Objective To analyze the status of real world studies (RWS) through registration information of the Chinese Clinical Trials Registry (ChiCTR). Methods The website of ChiCTR was searched with the real world as the search term to collect relevant registered items in the real world from inception to May 4, 2022. Descriptive analysis method was used. Results A total of 642 registered items were included. The median sample size was 482 cases. RWS were mainly observational studies, and the number of intervention studies was increasing year by year. There were 267 studies (41.59%) at the stage of post-marketing drugs or phase Ⅳ clinical trials. Most of the main measures were endpoints (56.23%), and the most commonly used was overall survival (15.79%). 62.15% of the registered projects met the minimum requirements for registration. Conclusion The number of RWS registered by ChiCTR shows an increasing trend. At present, the research purpose of RWSs is unclear, and the completeness of registered studies and the overall content compliance of the studies need to be improved.

Citation： WANG Shichun, LI Hongyan, MA Wenhao, YAN Siyu, HUANG Qiao, SHANG Hongcai, JIN Yinghui. Analysis of the status of real world studies based on the Chinese clinical trial registry. Chinese Journal of Evidence-Based Medicine, 2023, 23(1): 75-79. doi: 10.7507/1672-2531.202207081 Copy

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10.	陈君超. 从试验注册到结果公开进一步提高临床试验的透明化. 中国新药杂志, 2018, 27(20): 2357-2360.
11.	刘炳林. 药物临床试验中疗效指标的选择. 中国新药杂志, 2017, 26(18): 2113-2120.
12.	Angelis CD, Drazen JM, Frizelle FA, 等. 这项临床试验完成注册了吗. 国际医学杂志编辑委员会声明. 中国循证医学杂志, 2006, 6(4): 310-312.
13.	张俊华, 郑文科, 张伯礼, 等. 真实世界研究. 世界中医药, 2019, 14(12): 3101-3105.
14.	金鑫瑶, 郑文科, 张俊华, 等. 推进真实世界研究的透明化. 世界中医药, 2019, 14(12): 3106-3110.
15.	Statham EE, White SA, Sonwane B, et al. Primed to comply: Individual participant data sharing statements on ClinicalTrials. gov. PLoS One, 2020, 15(2): e0226143.
16.	吴泰相, 米娜瓦尔·阿不都, 卞兆祥, 等. 基于临床试验注册信息调查影响我国临床试验质量的因素. 中国循证医学杂志, 2018, 18(6): 526-531.
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1. Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence - what is it and what can it tell us. N Engl J Med, 2016, 375(23): 2293-2297.
2. 中国胸部肿瘤研究协作组. 真实世界研究指南(2018年版). Available at: https://guide.medlive.cn/guideline/16342.
3. 孙鑫, 谭婧, 王雯, 等. 建立真实世界数据与研究技术规范, 促进中国真实世界证据的生产与使用. 中国循证医学杂志, 2019, 19(7): 755-762.
4. 曹雪, 何丽云, 孟祥然, 等. 近10年中国真实世界临床研究应用热点及前沿分析. 世界中医药, 2022, 17(5): 620-624,629.
5. 孙鑫, 谭婧, 唐立, 等. 重新认识真实世界研究. 中国循证医学杂志, 2017, 17(2): 126-130.
6. 毛静远, 林姗姗, 王家莹, 等. 2007-2020年中医药治疗心血管疾病临床试验注册情况述评. 中医杂志, 2022, 63(7): 601-607.
7. 王靖雯, 邵明义, 符宇, 等. 国内真实世界临床研究方案设计的分析与思考. 中华中医药杂志, 2022, 37(4): 2125-2128.
8. 邬兰, 田国祥, 王行环, 等. 临床试验的注册及注册平台比较分析. 中国循证心血管医学杂志, 2017, 9(2): 129-134.
9. Lindsley K, Fusco N, Li T, et al. Clinical trial registration was associated with lower risk of bias compared with non-registered trials among trials included in systematic reviews. J Clin Epidemiol, 2022, 145: 164-173.
10. 陈君超. 从试验注册到结果公开进一步提高临床试验的透明化. 中国新药杂志, 2018, 27(20): 2357-2360.
11. 刘炳林. 药物临床试验中疗效指标的选择. 中国新药杂志, 2017, 26(18): 2113-2120.
12. Angelis CD, Drazen JM, Frizelle FA, 等. 这项临床试验完成注册了吗. 国际医学杂志编辑委员会声明. 中国循证医学杂志, 2006, 6(4): 310-312.
13. 张俊华, 郑文科, 张伯礼, 等. 真实世界研究. 世界中医药, 2019, 14(12): 3101-3105.
14. 金鑫瑶, 郑文科, 张俊华, 等. 推进真实世界研究的透明化. 世界中医药, 2019, 14(12): 3106-3110.
15. Statham EE, White SA, Sonwane B, et al. Primed to comply: Individual participant data sharing statements on ClinicalTrials. gov. PLoS One, 2020, 15(2): e0226143.
16. 吴泰相, 米娜瓦尔·阿不都, 卞兆祥, 等. 基于临床试验注册信息调查影响我国临床试验质量的因素. 中国循证医学杂志, 2018, 18(6): 526-531.
17. Tan AC, Askie LM, Hunter KE, et al. Data sharing-trialists' plans at registration, attitudes, barriers and facilitators: a cohort study and cross-sectional survey. Res Synth Methods, 2021, 12(5): 641-657.

Chinese Journal of Evidence-Based Medicine

Analysis of the status of real world studies based on the Chinese clinical trial registry

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