| Objective:The purpose of this study was to investigate the current situation and existing problems of the ethics committee of drug clinical trial institutions in Guangxi by questionnaire survey,so as to improve the ethical review ability of the ethics committee.At the same time,by means of literature review and expert consultation,a set of evaluation index system for ethical review of drug clinical trial in line with the reality in Guangxi was constructed to provide advice for the standardization of ethical review and the optimization of ethical organization of drug clinical trial.Methods:1.Literature analysis:Questionnaire and expert consultation forms were constructed by collecting literature,national and international policies and regulations related to drug clinical trial ethical review.By inquiring data on the official website of China Food and Drug Administration and China Clinical Trial Database,the number and distribution of drug clinical trial institutions in China were statisticed.2.Questionnaire survey:“Questionnaire of ethics organizational framework of drug clinical trial and its running situation in Guangxi”and“Expert consultation forms of evaluation index system of drug clinical trial ethical review in Guangxi”were made,which were conducted by the ethics committees of 11 drug clinical trial institutions in Guangxi and 20 experts from hospitals,medical universities,government administration departments and other related fields participated,respectively.3.Expert consultation:The index of each dimension and the weight of each index of drug clinical trial ethical review evaluation system were determined by expert consultation.Expert consultation was divided into two stages,which were"Consultation on the index of each dimension of ethical review evaluation system"and"Consultation on the index weight of ethical review evaluation system",respectively.Expert consultation was conducted several rounds in each stages until suggestion about determine index and its weight were united.4.Comprehensive scoring method:According to the indexes identified of dimension and weight in the first stage,the indexes were scored,and then the total score weighted of all indexes was calculated to construct comprehensive scoring model.5.Empirical study:The established comprehensive evaluation model and the weighted TOPSIS method were used to score 10 clinical trial projects completed which were selected randomly in a drug clinical trial institution from2015 to 2018 in Nanning,Guangxi.And then the ethical review evaluation corresponding ranking of each project was obtained.The correlation between the two ethical review evaluation ranking was analyzed to verify the rationality of the established comprehensive scoring model.Results:1.A total of 716 drug clinical trial institutions have been identified from February 2005 to July 2018 in China.And the top three were total 182(25.42%)institutions in Guangdong,Beijing and Jiangsu.A total of 11(1.54%)institutions were identified in Guangxi,including 8 institutions in Nanning,2institutions in Liuzhou and 1 institution in Guilin,which ranked 20th in China.2.Situation of ethics committee of drug clinical trial institutions in Guangxi(1)Organizational structure:7 out of 11 drug clinical trial institutions in Guangxi had set up specialized drug clinical trial ethics committee.Just One ethics committee had more than 20 members,three ethics committees had 15-20members and seven ethics committees had less than 15 members.Only six ethics committees had full-time secretaries.Only one ethics committee was an independent functional department.And only one ethics committee had passed CAP certification.(2)Personnel composition:There were total 155 members in the 11 ethics committees,and the personnel composition in each ethics committee ranged from 11 to 22,with an average of 14.There were 99(63.87%)males and 56(36.13%)females,and 73(58.87%)members with full senior titles,39(31.45%)members with associate senior titles,and 12(9.68%)members with intermediate titles.There were 85(54.84%)members of clinical medicine,18(11.61%)members of pharmacy,5(3.23%)members of nursing,8(5.16%)members of management,18(11.61%)members of law.There were 123(79.35%)members from their own units,the remaining members were from other units.There were9(56.25%)part-time secretaries and 7(43.75%)full-time secretaries.(3)Chairman and vice chairmen:Each ethics committee had one chairman and 0~2 vice chairmen.The sex ratio of the chairman was 8:3(male:female)and that of the vice-chairmen was 5:7.Most of the first majors of the chairmen and vice-chairmen were clinical medicine,but only one chairman was full-time,while the remaining chairmen and vice-chairmen were part-time.(4)Daily operation:Six(54.55%)ethics committees had independent office.Seven(63.64%)ethics committees were funded entirely by the review projects,and three(27.27%)were funded partially by their own hospitals.Three(27.27%)ethics committees stipulated that at least one review meeting should be held within a month,and four(36.36%)did not hold regular review meeting.Three(27.27%)ethics committees had not yet voted entirely by secret ballot to review decisions.(5)Ethics training:Forty five members(29.03%)participated in the national ethics training,and 81 members(52.26%)participated in the provincial ethics training.Four(36.36%)institutions regularly carried out ethics training more than three times a year,five(45.45%)institutions regularly carried out ethics training 1-3 times a year,and two(18.18%)institutions do not regularly carried out ethics training.3.Comprehensive scoring model:Four first-level indexes(organization and management,review rules,review process,supervision and administration),11secondary-level indexes and 47 third-level indexes were finally determined in ethical review evaluation index system through two rounds of expert consultation.The weight coefficients of the 4 first-level indexes were 0.25,0.25,0.30 and 0.20,respectively.Finally,a comprehensive scoring model for the ethical review evaluation system of drug clinical trial was established by quantifying and assigning values to each index and combining with the corresponding weight coefficient.4.Empirical research:Empirical research was conducted on comprehensive score model,evaluation sorting of 10 drug clinical trial projects(Project A,B,C,D,E,F,G,H,I,J)by the comprehensive score method was 6,10,7,1,2,9,4,5,8,3.And evaluation sorting by the weighted TOPSIS method was 6,9,7,2,1,10,4,5,8,3.A strong positive correlation was observed between the score rankings obtained by the two evaluation methods(R~2=0.976,P<0.001),which further verified the scientific nature of the comprehensive scoring model.Conclusion:1.Chinese drug clinical trial institutions were mainly concentrated in the eastern region.While drug clinical trial institutions in Guangxi were mainly concentrated in Nanning and were obviously less than those in other provinces,which reflected the uneven distribution of health resources to some extent in China.2.Ethics committee organization framework of drug clinical trial institutions had been built in Guangxi,the personnel structure was basically accord with the requirement of ethical review,ethics committee daily operation was relatively mature.But the ethics committees still lacked of independence,ethical review had not yet formed relatively uniform standard,ethics training also need to be strengthened.3.The study established a relatively reliable ethical review evaluation system for drug clinical trial,but the determination of indexes and weight in each index was subjective,which needed to be improved.The evaluation system had good operability,so each institution could better understand the ethical and scientific nature of drug clinical trial project according to the evaluation system.4.Through the practical application of the ethical review comprehensive evaluation model for drug clinical trials,the ethical review evaluation of different drug clinical trial projects could be realized,and the key factors affecting the quality of ethical review could be visualized,so as to provide a basis for improving the ethical review ability of the ethics committee. |
PDF Full Text Request