Management of Subjects in Phase I Clinical Trials for New Drug

亚洲社会药学

Management of Subjects in Phase I Clinical Trials for New Drug

Qian Cuihong, Lian Guiyu*

School?of?Business?Administration,?Shenyang?Pharmaceutical?University,?Shenyang?110016,?China

出版日期:2017-06-20 发布日期:2017-08-31

Management of Subjects in Phase I Clinical Trials for New Drug

Qian Cuihong, Lian Guiyu*

School?of?Business?Administration,?Shenyang?Pharmaceutical?University,?Shenyang?110016,?China

Online:2017-06-20 Published:2017-08-31
Contact: Lian Guiyu, associate professor. Major research area: pharmaceutical administration research. Tel: 18698849647, E-mail: lianguiyu@163.com.

摘要/Abstract

摘要： Objective To standardize management of subjects in phase I clinical trials, reduce the risks of trials and to ensure the quality of trials. Methods Risk management was used to analyze main links of management of subjects, and to find out the major risk points and factors. Results and Conclusion Poor compliance of subjects is a major risk factor. The compliance of subjects and the quality of clinical trials can be improved by standardizing management of subjects.

关键词: phase I clinical trials, subjects, managemen

Abstract: Objective To standardize management of subjects in phase I clinical trials, reduce the risks of trials and to ensure the quality of trials. Methods Risk management was used to analyze main links of management of subjects, and to find out the major risk points and factors. Results and Conclusion Poor compliance of subjects is a major risk factor. The compliance of subjects and the quality of clinical trials can be improved by standardizing management of subjects.

Key words: phase I clinical trials, subjects, managemen

Qian Cuihong, Lian Guiyu. Management of Subjects in Phase I Clinical Trials for New Drug [J]. 亚洲社会药学.

Qian Cuihong, Lian Guiyu. Management of Subjects in Phase I Clinical Trials for New Drug [J]. Asina Journal Of Social Pharmacy.

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亚洲社会药学

Management of Subjects in Phase I Clinical Trials for New Drug

Management of Subjects in Phase I Clinical Trials for New Drug

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