药物生物等效性临床试验中不依从/违背方案特点分析及管理策略  

Features analysis and management strategies for non-compliance/violation in bioequivalence studies

作　　者：周运翱[1] 田晓花 郝晓花[1] 杨志云[1] 贾王彦 吴国安[1] ZHOU Yun-ao;TIAN Xiao-hua;HAO Xiao-hua;YANG Zhi-yun;JIA Wang-yan;WU Guo-an(Beijing Dian Hospital Affiliated to Capital Medical University,Beijing 100015,China)

机构地区：[1]首都医科大学附属北京地坛医院,北京100015

出　　处：《中国新药杂志》2020年第8期858-863,共6页Chinese Journal of New Drugs

基　　金：北京市属医院科研培育计划资助项目(PG2020033):基于健康受试者参加临床试验动机调查探索受试者权益保护的策略研究。

摘　　要：目的:在药物临床试验中,不依从/违背方案时有发生,是影响临床试验质量及可能损害受试者权益的重要因素。生物等效性(BE)临床试验从方案设计、入组人群、试验流程、病房管理等各方面不同于Ⅱ~Ⅳ期临床试验,不依从/违背方案的特点可能存在特殊性。方法:本研究对北京地坛医院近4年来药物BE临床试验发生的不依从/违背方案进行回顾性研究,分析不依从/违背方案的发生率、频数、类别、分布等特点,探讨BE临床试验不依从/违背方案管理策略。结果:研究结果显示,药物BE临床试验实施过程中,不依从/违背方案具有聚集性、群发性特点,且各不依从/违背方案以超窗类(占75. 84%)、研究者责任(占86. 84%)、轻微(占98. 56%)的为主。结论:建立完善的质量控制体系及受试者保护体系,有利于提高BE临床试验质量和保护受试者权益。Objective: To analyze the features of non-compliance/violations in bioequivalence studies,which are inevitable and may affect the quality of the clinical trials and the rights and interests of the subjects,and put forward management strategies for the non-compliance/violations. Methods: Due to the fact that bioequivalence studies are different from phase Ⅱ,Ⅲ,and Ⅳ clinical trials in protocol design,enrolled population,trial process,and ward management,the non-compliance/violations in phase I clinical trials may have some special features. In this study,we retrospectively studied the non-compliance/violations in phase I drug clinical trials carried out at Beijing Ditan Hospital,Capital Medical University in the past four years,analyzed the incidence,frequency,type,distribution and other features of the on-compliance/violations,and discussed the management strategies for the non-compliance/violations in phase I drug clinical trials. Results: The non-compliance/violations during the implementation of bioequivalence study had the characteristics of continuity,aggregation,and clustering. The noncompliance/violations were dominated by out of time window( 75. 84%),researcher ’s responsibilities( 86.84%),and slight ones( 98. 56%). Conclusion: The establishment of a complete quality control system and subject protection system is conducive to improving the quality of clinical trials and protecting the rights and interests of subjects.

关 键 词：生物等效性临床试验 不依从/违背方案 特点 影响因素 管理策略 

分 类 号：R95[医药卫生—药学]