某院药物临床试验受试者脱落原因浅析及对策探讨

目的分析药物临床试验中影响受试者脱落的主要因素,探讨提高受试者依从性的策略。方法分析某院2009年1月至2011年10月48项的药物临床试验资料,共954例门诊受试者,其中11项为国际多中心药物临床试验。在对受试者脱落的原因分析基础上探讨提高受试者依从性的多项策略。结果 954例受试者中,66例受试者脱落。3项国际多中心试验无一例脱落。受试者个人因素致脱落的占4.55%;药物和试验方案因素是主要的影响因素,占62.13%;环境因素致脱落的占33.32%。近年药物临床试验的国际化发展,对受试者的依从性要求更高。结论应在药物临床试验的各个阶段实施针对性措施,对受试者充分知情同意、进行依从性教育、建立良好的医患关系、积极处理不良事件,多方面提高受试者依从性,从而提高药物临床试验质量。

Cause analysis and countermeasures of subjects expulsion in clinical drug trials

Objective To analyze the main factors affecting the compliance of the subjects in drug clinical trial and explore the methods of compliance management.Methods Analyze was conducted on 48 drug clinical trials since January 2009 in our hospital,including 954 outpatients trial cases.The causes of drop-out in drug clinical trial were analyzed and the strategies of improving the compliance of subject were discussed deeply.Results Among 954 cases,there were 66 drop-outs.None drop out in three international multi-center trials.The rate of drop-out cases due to personal reasons and environment reasons was 4.55% and 33.32%,respectively.The drug and trial reasons were main factors influencing drop-out,the rate was 62.13%.In recent years,the international development of the clinical trial made the compliance requirements higher.Conclusion Using appropriate,flexible and various measures in the various stages of clinical trials.Informing fully consent to the subjects,carrying out the compliance educaiton to subjects,establishing a good doctor-patient relationship and dealing actively with adverse events would improve the compliance of the subjects,which will enhance the the quality of the drug clinical trials.