Analysis of different dimensions and related factors of compliance of clinical researchers_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Zhi ^1,2 , ZHAO Chen ¹ , GAO Rui ¹ , WANG Zhen ³ , WANG Hui ^1,2 ,  SHANG Hongcai ⁴

1. Tianjin University of Traditional Chinese Medicine, Tianjin, 300192, P.R.China;
2. Tianjin Modern Traditional Chinese Medicine Key Laboratory, Provincial Department to Build a National Key Laboratory Breeding Base, Tianjin, 300192, P.R.China;
3. Tianjin CLINDA Medical Technology Co.,Ltd, Tianjin, 300384, P.R.China;
4. The Ministry of Internal Medicine of TCM and The Key Laboratory of Beijing, Beijing University of Traditional Chinese Medicine, Beijing, 100700, P.R.China;

Corresponding author：

SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Clinical researcher; Compliance; Clinical trial; Data management

DOI：

10.7507/1672-2531.201711040

Video：

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Poor compliance in clinical studies is a risk factor leading to bias of results of clinical research. However, while the subject compliance has received extensive attention, researcher compliance has not been paid enough attention. The problem of researcher compliance runs through the whole process of clinical research. How to control and evaluate the researcher compliance is the key problem in clinical research. Based on the current situation of poor compliance of clinical researchers, this paper summaried the information of five different dimensions that affects the researcher compliance in clinical research, clarified the relevant factors that may affect the researcher compliance in the process of clinical research, and analyzed the influence of the factors related to the researcher compliance on the quality control of clinical research, hence establishing a foundation for further research on control strategies and evaluation techniques of researcher compliance.

Citation： LIU Zhi, ZHAO Chen, GAO Rui, WANG Zhen, WANG Hui, SHANG Hongcai. Analysis of different dimensions and related factors of compliance of clinical researchers. Chinese Journal of Evidence-Based Medicine, 2018, 18(9): 979-983. doi: 10.7507/1672-2531.201711040 Copy

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24.	杜武勋, 朱明丹, 袁宏伟, 等. 病证结合方证相应的系统-系统的方证相应动态研究. 中国中西医结合杂志, 2012, 32(6): 839-842.
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26.	梁茂新, 王雪峰. 中医疗效评价指标和方法研究需要解决的认识问题. 世界科学技术, 2006, 8(1): 31-35.

1. 张莉, 徐建江, 康长青, 等. 临床试验研究人员对培训的意向及行为分析. 中国医药导报, 2016, 13(4): 148-149.
2. 张君, 李国信, 张锡玮. 谈新药临床试验中受试者和研究者依从性问题. 辽宁中医杂志, 2005, 32(8): 854.
3. 曾倩, 陈冠民, 李汝霖. 新药临床试验中受试者的依从性问题. 中国新药与临床杂志, 2003, 22(9): 568-569.
4. 国家食品药品监督管理局.药品临床试验管理规范(GCP), 1999-09-01.
5. 曾令峰, 刘军, 潘建科, 等. 药物临床试验痴呆弱势群体与权益保障伦理学问题研究. 中国新药杂志, 2016, 25(24): 2793-2794.
6. 王頔, 杨竟, 陈仲林, 等. 2013年版《赫尔辛基宣言》的修订及其意义的分析研究. 中国医学伦理学, 2015, 28(4): 618-621.
7. 赵金鑫, 张筱, 沈黎. 药物临床试验的伦理问题与对策分析. 齐齐哈尔医学院学报, 2016, 37(21): 2748.
8. 文谦, 吕建琴, 杨扬, 等. 提高研究者依从性,提升针灸临床研究质量-关于针灸医生和针灸研究者角色冲突思考. 中国针灸, 2016, 36(6): 561-562.
9. 林洪生, 刘杰, 李勇, 等. 多中心中医临床研究的实施管理与质量控制实践. 世界科学技术-中医药现代化, 2012, 14(1): 1278.
10. 许卫华, 梁伟雄, 王奇, 等. 临床研究者低依从性的表现、原因及对策. 中药新药与临床药理, 2009, 20(3): 288-290.
11. 孙塑伦, 翁维良, 杨龙会. 中医临床研究实施过程质控与管理. 北京: 中国中医药出版社, 2010: 58.
12. Cao HB, Shang HC, Mu W, et al. Internal challenge to clinical trial project management: strategies for managing investigator compliance. J Evid Based Med, 2013, 6(3): 157-166.
13. Bernard L, Marilyn J. Conflict of interest in medical research, education, and practice. Washington (DC): national academies press, 2009: 46.
14. Rochon PA, Gurwitz JH, Simms RW, et al. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med, 1994, 154(2): 157-163.
15. Perlis RH, Perlis CS, Wu YP, et al. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am J Psychiatry, 2005, 162(10): 1957-1960.
16. Bekelman Je, Li Y, Gross GP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA, 2003, 289(4): 454-465.
17. U.S.Food and Drug Administration. Financial Disclosure by Clinical Investigators. Available at: http://www.accessdata.fda.gov/scripts/cdrh/efdoes/efefr/CFRSearch.cfm.2008-04-01.2008-07-14.
18. 李歆, 王琼, 刘利萍. 药物临床试验中研究者经济利益冲突的法律调控初探. 中国药房, 2009, 20(22): 1687-1688.
19. 张敏. 药物临床试验研究者利益冲突问题研究. 药物流行病学杂志, 2014, 23(1): 5.
20. 国家食品药品监督管理总局.药物临床试验质量管理规范. 2003-09-01.
21. 国家食品药品监督管理总局.药物临床试验质量管理规范修订稿(征求意见稿). 2015-02-06.
22. 国家食品药品监督管理总局.药物临床试验机构资格认定检查细则(试行). 2014-09-05.
23. Available at: http://www.ich.org/ichnews/newsroom/read/article/ich-q3cr6-guideline-reaches-step-4-of-the-ich-process-copy-1.html.
24. 杜武勋, 朱明丹, 袁宏伟, 等. 病证结合方证相应的系统-系统的方证相应动态研究. 中国中西医结合杂志, 2012, 32(6): 839-842.
25. 安宇, 王阶, 何庆勇, 等. 对中药新药研发的思考. 中国中医药信息杂志, 2014, 21(4): 1-2.
26. 梁茂新, 王雪峰. 中医疗效评价指标和方法研究需要解决的认识问题. 世界科学技术, 2006, 8(1): 31-35.

Chinese Journal of Evidence-Based Medicine

Analysis of different dimensions and related factors of compliance of clinical researchers

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