药物临床试验方案对受试者依从性的影响及管理策略
|
摘要
目的分析药物临床试验方案对受试者依从性影响的特点,探讨提高受试者依从性的策略。方法选取该院2017—2018年8项药物临床试验项目的入组受试者共82例进行分析。结果无按时按量使用试验药物、无按时到医院回访做相关检查和无按照要求填写每日记录是受试者无遵照研究方案的最主要的原因。临床试验方案设计因素中,口服途径、上市后研究、少于6个月的访视时间、每季度的回访频率、整个项目少于3次的检查、补偿总额少于1 000元的项目,受试者依从性较好(P<0.05);对于治疗环境因素,门诊受试者和住院受试者的影响程度无明显差别(P>0.05)。结论通过在试验立项时对试验方案复杂程度进行评估、受试者入组后进行充分知情和依从性教育、试验实施阶段试验机构管理流程的顺畅、积极开展相关的临床试验知识宣传等措施,将对提高受试者依从性起到积极重要的作用。
Objective To analyze the characteristics of drug clinical trials on subject compliance and to explore strategies to improve subject compliance. Methods A total of 82 subjects from 8 clinical trials of the drug from 2017 to 2018 were selected for analysis. Results Failure to use the test drugs on time and in volume, without returning to the hospital on time for relevant examinations and not completing the daily records as required was the most important reason for the subjects not following the study protocol. Among the design factors of clinical trial plan, oral route, post-marketing study, visit time of less than 6 months, frequency of return visits per quarter, less than 3 inspections of the whole project, and projects with total compensation less than 1 000 yuan, the test The adherence was better(P<0.05); there was no significant difference in the degree of influence between the outpatients and the hospitalized subjects on the treatment of environmental factors(P>0.05).Conclusion By assessing the complexity of the trial program at the time of trial establishment, fully informed and compliant education after enrollment, smooth management of the trial organization during the trial implementation phase, and active implementation of relevant clinical trial knowledge and other measures, which plays a positive and important role in improving subject compliance.
Objective To analyze the characteristics of drug clinical trials on subject compliance and to explore strategies to improve subject compliance. Methods A total of 82 subjects from 8 clinical trials of the drug from 2017 to 2018 were selected for analysis. Results Failure to use the test drugs on time and in volume, without returning to the hospital on time for relevant examinations and not completing the daily records as required was the most important reason for the subjects not following the study protocol. Among the design factors of clinical trial plan, oral route, post-marketing study, visit time of less than 6 months, frequency of return visits per quarter, less than 3 inspections of the whole project, and projects with total compensation less than 1 000 yuan, the test The adherence was better(P<0.05); there was no significant difference in the degree of influence between the outpatients and the hospitalized subjects on the treatment of environmental factors(P>0.05).Conclusion By assessing the complexity of the trial program at the time of trial establishment, fully informed and compliant education after enrollment, smooth management of the trial organization during the trial implementation phase, and active implementation of relevant clinical trial knowledge and other measures, which plays a positive and important role in improving subject compliance.
引文
[1]李轩,洪亮,邵蓉.完善我国药物临床试验受试者管理分析[J].现代商贸工业,2013(6):140-142.
[2]张莉,郭晋敏.我院药物临床试验受试者管理分析及对策[J].中国医药导报,2015,12(6):140-144.
[3]曹羽明,曹越.潜在受试者对药物临床试验认知的调查[J].医药导报,2017,36(2):226-230.
[4]刘朝,杨金生,陈敏,等.香港地区针灸戒烟受试者的依从性影响因素分析[J].北京中医药大学学报,2016,39(1):82-88.
[5]张抗,李文元,冯硕,等.临床试验中脱落、退出和失访病例的统计学处理和报告规范[J].中医杂志,2016,57(14):1204-1207.
[6]田少雷,绍庆翔.药物临床试验与GCP实用指南[M].北京:北京大学医学出版社,2012:16.
[7]王帅,毛静远,王贤良,等.多中心临床研究中受试者依从性的影响因素及应对措施[J].中国循证心血管医学杂志,2013,5(2):104-106.
[8] Haynes RB,Dantes R.Patient compliance and the conduct and interpretation of therapeutic trials[J].Control Clin Trials,1987,8(1):12-19.
[9]范大超.入组率的分析方法以及受试者的依从性[J].中国处方药,2010,96(3):70-71.
[10] CCTS工作组,贺佳(执笔).临床试验统计分析计划及统计分析报告的考虑[J].中国卫生统计,2015,32(3):550-552.
[11]王帅,毛静远,王贤良,等.多中心临床研究中受试者依从性的影响因素及应对措施—基于芪参益气滴丸治疗冠心病心力衰竭临床评价研究实施的探讨[J].中国循证心血管医学杂志,2013,5(12):104-106.
[12]李轩,邵蓉.药物临床试验进度延误影响因素分析[J].现代商贸工业,2013,8(1):185-186.
[13]赵励彦,侯宇.受试者对于研究补偿的观点调查[J].医学科研伦理,2017,38(9A):34-51.
[2]张莉,郭晋敏.我院药物临床试验受试者管理分析及对策[J].中国医药导报,2015,12(6):140-144.
[3]曹羽明,曹越.潜在受试者对药物临床试验认知的调查[J].医药导报,2017,36(2):226-230.
[4]刘朝,杨金生,陈敏,等.香港地区针灸戒烟受试者的依从性影响因素分析[J].北京中医药大学学报,2016,39(1):82-88.
[5]张抗,李文元,冯硕,等.临床试验中脱落、退出和失访病例的统计学处理和报告规范[J].中医杂志,2016,57(14):1204-1207.
[6]田少雷,绍庆翔.药物临床试验与GCP实用指南[M].北京:北京大学医学出版社,2012:16.
[7]王帅,毛静远,王贤良,等.多中心临床研究中受试者依从性的影响因素及应对措施[J].中国循证心血管医学杂志,2013,5(2):104-106.
[8] Haynes RB,Dantes R.Patient compliance and the conduct and interpretation of therapeutic trials[J].Control Clin Trials,1987,8(1):12-19.
[9]范大超.入组率的分析方法以及受试者的依从性[J].中国处方药,2010,96(3):70-71.
[10] CCTS工作组,贺佳(执笔).临床试验统计分析计划及统计分析报告的考虑[J].中国卫生统计,2015,32(3):550-552.
[11]王帅,毛静远,王贤良,等.多中心临床研究中受试者依从性的影响因素及应对措施—基于芪参益气滴丸治疗冠心病心力衰竭临床评价研究实施的探讨[J].中国循证心血管医学杂志,2013,5(12):104-106.
[12]李轩,邵蓉.药物临床试验进度延误影响因素分析[J].现代商贸工业,2013,8(1):185-186.
[13]赵励彦,侯宇.受试者对于研究补偿的观点调查[J].医学科研伦理,2017,38(9A):34-51.