新药Ⅰ期临床试验健康受试者筛选失败原因分析

新药Ⅰ期临床试验健康受试者筛选失败原因分析

王菊勇,李雪,陈潮,崔文静

上海中医药大学附属龙华医院I期临床试验研究室,上海中医药大学附属龙华医院I期临床试验研究室,上海中医药大学附属龙华医院I期临床试验研究室,上海中医药大学附属龙华医院I期临床试验研究室

收稿日期:2018-12-04 修回日期:2018-12-04 出版日期:2018-12-25
基金资助:
十三五“重大新药创制”科技重大专项（项目编号：2017ZX09304001；项目名称：恶性肿瘤等疾病示范性中药新药临床评价技术平台建设）

Analysis of Failure Reasons of Screening for Healthy Subjects in Phase Ⅰ Clinical Trials of New Drug

WANG Juyong,LI Xue,CHEN Chao and CUI Wenjing

Clinical Laboratory of Phase I,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,200032;China,Clinical Laboratory of Phase I,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,200032;China,Clinical Laboratory of Phase I,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,200032;China,Clinical Laboratory of Phase I,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,200032;China

Received:2018-12-04 Revised:2018-12-04 Online:2018-12-25

摘要/Abstract

摘要： 目的：探讨新药Ⅰ期临床试验过程中健康受试者筛选失败的主要原因及提高筛选成功率的对策。方法：针对255例健康成年受试者参加某项治疗慢性乙型肝炎（chronic hepatitis B，CHB）新药的生物等效性（bioequivalency，BE）临床试验筛选情况，分析受试者筛选失败的原因及其影响因素。结果：本试验项目筛选合格并入组的健康受试者共64例（25.10%）。受试者筛选失败的主要原因包括实验室化验检查异常(34.90%)；腹部B超检查异常(10.59%)；研究首次用药前3个月内参加过其他临床试验(8.24%)；撤回知情同意书(8.63%)。结论：充分知情、加强受试者信息化管理及适宜的检查是提高受试者的筛选成功率的关键。

Abstract: Objective：To investigate the reasons for the failure of screening healthy subjects and the measures to improve screening success rate in phaseⅠ clinical trials of new drug. Methods： In 255 healthy adult subjects who participated in the subject screening of a bioequivalence(BE) clinical trial for a chronic hepatitis B (CHB) new drug， the reasons for the failure of the screening and its influencing factors were analyzed. Results： Sixtyfour healthy subjects (25.10%) were eventually chosen into the trial.The main reasons for the failure of selection healthy subjects included abnormal laboratory tests (34.90%)， abnormal abdominal B-ultrasound (10.59%)， the participation of other clinical trials within 3 months before the first drug use of the study (8.24%)，withdrawal of informed consent (8.63%). Conclusion： The key to improve the success rate of subject screening is to be fully informed，to make use of the electronic systems and proper examination.

王菊勇,李雪,陈潮,崔文静. 新药Ⅰ期临床试验健康受试者筛选失败原因分析[J]. .

WANG Juyong,LI Xue,CHEN Chao and CUI Wenjing. Analysis of Failure Reasons of Screening for Healthy Subjects in Phase Ⅰ Clinical Trials of New Drug[J]. .

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