Development and influencing factors of compliance behaviors of investigators in clinical trials.
The development and influencing factors of compliance behavior of investigators in clinical trials were explored. According to literature review, a hypothetical model of development of compliance behavior of investigators in clinical trials was established, and the influencing factors of compliance behavior of investigators and their interrelationships were studied based on questionnaire survey of five hundred investigators sampled randomly from one hundred clinical trial institutions in China. Cronbach's alpha coefficient and structural equation modeling were adopted to empirically analyze the results. Six variables in the hypothetical model were included: compliance behavior of investigators, credibility of clinical trial, capability of government regulation, quality control of sponsor, quality control of clinical institution and compliance intention of investigators. Empirical analysis showed that the compliance behavior of investigators in clinical trial was directly affected by compliance intention of investigators, quality control of sponsor and quality control of clinical institution. In addition, credibility of clinical trial and capability of government regulation indirectly affected the compliance behavior of investigators in clinical trial through influencing the compliance intention of investigators, quality control of sponsor and quality control of clinical institution. Quality control of sponsor was affected by credibility of clinical trial and capability of government regulation while quality control of clinical institution was only influenced by capability of government regulation.
School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Yu-Hong
YH
Shen
China Food and Drug Administration, Beijing, 100061, China.
Mao-Zhong
MZ
Li
School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. xpzhang602@163.com.
Xin-Ping
XP
Zhang
China Food and Drug Administration Center for Certification of Drug, Beijing, 100061, China.
Zheng-Qi
ZQ
Li
School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Li-Jun
LJ
Wang
D002681:China; D002986:Clinical Trials as Topic; D006801:Humans; D011786:Quality Control; D012108:Research Personnel; D011795:Surveys and Questionnaires