摘要
目的分析临床指标评判对Ⅰ期药物临床试验健康受试者筛选过程中的影响并提出改善措施。方法2019年4月—2020年7月从蚌埠医学院第一附属医院Ⅰ期药物临床试验机构已完成项目中,筛选出符合要求的健康受试者项目以及健康受试者筛选过程记录。对筛选失败原因进行统计分析,探讨临床指标评判在筛选失败过程中的主要影响因素。结果1640例健康受试者筛选记录中,632例(38.5%)筛选成功,1008例(61.5%)筛选失败。健康受试者筛选失败主要因素依次为实验室检查、生命体征检查、自愿退出、心电图检查、身高/体质量检查等。其中,实验室检查(异常475例,占47.12%)和心电图检查(异常88例,占8.73%)作为临床研究指标成为影响健康受试者筛选成功与否的重要因素。结论针对筛选过程中的实验室指标正常值范围波动和心电图检查报告,经临床医师判断各项指标的医学决定水平(medicine decide level,MDL),若无临床意义时可以考虑纳入。制定科学合理的入选和排除标准,完善项目方案,将有助于提高健康受试者筛选成功率。
Objective To analyse the influences of clinical indicators evaluation in the screening process for phaseⅠclinical trials and improving strategies.Methods From April 2019 to July 2020,the completed projects of the First Affiliated Hospital of Bengbu Medical College,the eligible healthy subjects'projects and the records of the screening process of healthy subjects were screened out.Reasons for screening failure were statistically analysed,and conducted to explore the main influencing factors for clinical indicators evaluation in screening failure process.Results Among the 1640 healthy subjects,632(38.5%)successfully passed screening,and 1008(61.5%)failed screening.The main failure factors of healthy subjects were laboratory test,vital sign examination,withdrawal of informed consent,electrocardiogram(ECG)examination,height/weight examination and so on.Among them,abnormal laboratory test results(475,accounting for 47.12%)and abnormal ECG examination results(88,accounting for 8.73%)were important factors affecting the healthy subject screening failure as clinical research indicators.Conclusion Regarding fluctuations in the normal ranges of laboratory indicators and ECG examination reports during the screening process,clinicians should determine the medical decision level(MDL)of each indicator.If no clinical significance is identified,then the subject can be included.Therefore,developing scientific inclusion,exclusion criteria and improving project protocols will help to improve the healthy subject screening success rate.
作者
郭润芳
李尚
魏海飞
李泽
杨飞龙
靳常胜
张茜
GUO Runfang;LI Shang;WEI Haifei;LI Ze;YANG Feilong;JIN Changsheng;ZHANG Qian(School of Publice Health Management,Bengbu Medical College,Bengbu Anhui 233030,China;School of Health Management,Bengbu Medical College,Bengbu Anhui 233030,China;National Drug Clinical Trial Institution,the First Affiliated Hospital of Bengbu Medical College,Bengbu Anhui 233004,China)
出处
《中国卫生标准管理》
2023年第10期115-119,共5页
China Health Standard Management
基金
蚌埠医学院科研课题自然重点科技项目(2022byzd068)
大学生创新创业训练计划项目(S202110367059)。
关键词
临床指标评判
Ⅰ期药物临床试验
健康受试者
入排标准
筛选失败
影响因素
clinical indicators evaluation
phaseⅠclinical trials
healthy subjects
inclusion and exclusion criteria
screening failure
influencing factors
