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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Abstract Full text Figures/Tables Video References Cited by

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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6.	毛靜遠, 林姍姍, 王家瑩, 等. 2007-2020年中醫藥治療心血管疾病臨床試驗注冊情況述評. 中醫雜志, 2022, 63(7): 601-607.
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13.	張俊華, 鄭文科, 張伯禮, 等. 真實世界研究. 世界中醫藥, 2019, 14(12): 3101-3105.
14.	金鑫瑤, 鄭文科, 張俊華, 等. 推進真實世界研究的透明化. 世界中醫藥, 2019, 14(12): 3106-3110.
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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. 中國胸部腫瘤研究協作組. 真實世界研究指南(2018年版). Available at: https://guide.medlive.cn/guideline/16342.
3. 孫鑫, 譚婧, 王雯, 等. 建立真實世界數據與研究技術規范, 促進中國真實世界證據的生產與使用. 中國循證醫學雜志, 2019, 19(7): 755-762.
4. 曹雪, 何麗云, 孟祥然, 等. 近10年中國真實世界臨床研究應用熱點及前沿分析. 世界中醫藥, 2022, 17(5): 620-624,629.
5. 孫鑫, 譚婧, 唐立, 等. 重新認識真實世界研究. 中國循證醫學雜志, 2017, 17(2): 126-130.
6. 毛靜遠, 林姍姍, 王家瑩, 等. 2007-2020年中醫藥治療心血管疾病臨床試驗注冊情況述評. 中醫雜志, 2022, 63(7): 601-607.
7. 王靖雯, 邵明義, 符宇, 等. 國內真實世界臨床研究方案設計的分析與思考. 中華中醫藥雜志, 2022, 37(4): 2125-2128.
8. 鄔蘭, 田國祥, 王行環, 等. 臨床試驗的注冊及注冊平臺比較分析. 中國循證心血管醫學雜志, 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. 陳君超. 從試驗注冊到結果公開進一步提高臨床試驗的透明化. 中國新藥雜志, 2018, 27(20): 2357-2360.
11. 劉炳林. 藥物臨床試驗中療效指標的選擇. 中國新藥雜志, 2017, 26(18): 2113-2120.
12. Angelis CD, Drazen JM, Frizelle FA, 等. 這項臨床試驗完成注冊了嗎. 國際醫學雜志編輯委員會聲明. 中國循證醫學雜志, 2006, 6(4): 310-312.
13. 張俊華, 鄭文科, 張伯禮, 等. 真實世界研究. 世界中醫藥, 2019, 14(12): 3101-3105.
14. 金鑫瑤, 鄭文科, 張俊華, 等. 推進真實世界研究的透明化. 世界中醫藥, 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. 吳泰相, 米娜瓦爾·阿不都, 卞兆祥, 等. 基于臨床試驗注冊信息調查影響我國臨床試驗質量的因素. 中國循證醫學雜志, 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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