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临床研究者依从性不同维度及相关因素分析 被引量:5

Analysis of different dimensions and related factors of compliance of clinical researchers
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摘要 临床研究中依从性不佳是导致临床研究结果产生偏倚的危险因素之一,但在受试者依从性得到广泛重视的同时,研究者依从性却未引起充分关注。研究者依从性问题贯穿于临床研究过程的始终,如何控制、评价研究者依从性是临床研究中的关键问题。本文从临床研究者依从性不佳的现状入手,归纳、总结了临床研究中影响研究者依从性的5种不同维度的因素,并分析了研究者依从性相关因素对临床研究质量控制的影响,为进一步开展研究者依从性控制策略和评测技术的研究奠定基础。 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.
作者 刘智 赵晨 高睿 王祯 王辉 商洪才 LIU Zhi;ZHAO Chen;GAO Rui;WANG Zhen;WANG Hui;SHANG Hongcai(Tianjin University of Traditional Chinese Medicine,Tianfin,300192,P.R.China;Tianfin Modern Traditional Chinese Medicine Key Laboratory,Provincial Department to Build a National Key Laboratory Breeding Base,Tianjin,300192,P.R.China;Tianfin CLINDA Medical Technology Co.,Ltd,Tianfin,300384,P.R.China 4.The Ministry of Internal Medicine of TCM and The Key Laboratory of Belting,Beijing University of Traditional Chinese Medicine,Beijing,100700,P.R.China)
出处 《中国循证医学杂志》 CSCD 北大核心 2018年第9期979-983,共5页 Chinese Journal of Evidence-based Medicine
基金 国家自然科学基金项目(编号:81503456)
关键词 临床研究者 依从性 临床试验 数据管理 Clinical researcher Compliance Clinical trial Data management
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