Asina Journal Of Social Pharmacy ›› 2016, Vol. 11 ›› Issue (1): 7-18.

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Factors Affecting the Safety of Drug Clinical Trials

Tang Xiaomei, Wang Shuling*   

  1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • Online:2016-01-07 Published:2016-01-07
  • Contact: Wang Shuling, associate professor. Major research area: drug market management. Tel: 13998302138, E-mail: lingyi50@163.com

Abstract: Objective To promote the development of drug clinical trials. Methods Thirty experts of drug clinical trials were interviewed through analytic hierarchy process (ahp) to obtain the factors affecting the safety of drug clinical trials. And Matlab software was used to analyze the weight of each factor so that a systematic evaluation of the factors could be made. Result and Conclusion Laboratory inspection process and sense of responsibility of adverse event related staffs were the key factors affecting the safety of drug clinical trials; the system of drug clinical trials was in the second place; and the management of the organization was in the last place. Therefore, it is suggested that a perfect system should be established to improve the quality of related staffs and to strengthen the supervision so as to protect the interests of the subjects in drug clinical trials.

Key words: clinical trials, safety, factor

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