药物临床试验质量控制及相关因素调查分析

Survey analysis of drug clinical trials quality control and its related factors

目的分析药物临床试验质量控制因素及其影响因素,并提出相应对策。方法以药物临床试验质量管理规范（GCP）的掌握程度、知情同意的执行情况、受试者的入组情况、数据的记录、合并用药、实验室异常值复查、受试者依从性、试验用药物管理、不良事件的处理等内容为参照制定调查问卷,对研究者进行调查分析。结果在本研究中,7个质量控制因素（知情同意的获取、研究者依从性、数据记录、实验室检查异常值复查、受试者依从性、试验用药物管理、不良事件的处理）的一致性α系数〉0.8,说明调查问卷具有较好的信度,可靠性较高。且本研究所选用的调查项目具有较好的内容效度。对调查对象的性别、年龄、职称等指标进行评估,结果显示男性与女性构成比例相当,无统计学差异（P〉0.05）;〈35岁、35~45岁、〉45岁者的比例相差较大,差异有统计学意义（P〈0.05）;副高以上调查对象、硕士及以上学历背景者相对较多,差异有统计学意义（P〈0.05）。由此可见,药物临床试验的研究者多为高学历、具有丰富临床经验和专业技能者。对调查对象的性别、年龄、职称、文化程度等指标进行评估,除年龄较大研究者在＂知情同意的获取＂和＂研究者依从性＂更具优势及具有高职称的研究者在＂知情同意的获取＂和＂受试者依从性＂更具优势外,其余均对药物临床试验质量控制因素不存在显著性影响。结论在药物临床试验中,对所有研究者普及GCP培训至关重要,只有严格遵守GCP,才能保障其受试者的合法权益。

Objective To analyze the influencing factors of drug clinical trials quality control and put forward the corre- sponding countermeasures. Methods The questionnaire including related contents [ e. g, mast degree of the Good Clinical Practice of Pharmaceutical Products （GCP） knowledge ,implementation status of informed consent, condition of subjects in the group, data record, drug combination, reexamining of abnormal laboratory values, compliance of subjects, experimental drug management, disposing of adverse events ] was made to survey on researchers. Results The alpha coefficient of con- sistency of seven quality control factors （ acquisition of informed consent, compliance of researchers, data record, reexami- ning of abnormal laboratm：~ values, compliance of subjects, experimental drug management, disposing of adverse events） was more than 0.8 in this study, as such, it was suggested that the questionnaire had better reliability. Moreover, the selected survey items in this study had better content validity. The results evaluating on some indicators such as respondents, gender, age ,job title showed that the constituent ratio of male and female was similar （P 〉 0.05 ） ;the ratios of ages 〈 35,35 -45 and 〉 45 years had significant difference （ P 〈 0.05 ） ; the respondents of vice-senior title and above and education back- ground of master＇s degree and above were relatively more （P 〈0.05） ,thus it can be found that the most researchers en- gaged in drug clinical trials had high education background and rich clinical experience as well as specialized skill. The re- suits evaluating on respondents, gender, age ,job title and education background showed that the researchers of older age had the superiors in ＂acquisition of informed consent＂ and ＂adherence of researchers＂ as well as the higher job title had the superiors in ＂acquisition of informed consent＂ and ＂compliance of subjects＂, but there were no significant effects of gen- der, education background on quality control in clinical drug trials. Conclusions In drug clinical trials, the popularization and training of GCP is very important for all researchers. Only when GCP is strictly followed, the respondents＇ lawful right can be ensured.