摘要
肿瘤临床试验是新药研发和治疗方法评估的重要手段,伦理审查是保障受试者权益和安全的重要环节。因此,建立肿瘤临床试验伦理审查互认机制具有重要的现实意义,可提高审批效率、减少重复审查、降低伦理风险、促进国际合作。本文通过文献分析和调研,对国内外肿瘤临床试验伦理审查互认发展现状进行了全面的分析和总结。研究结果表明,肿瘤临床试验伦理审查互认已成为国际共识,并在全球范围内得到广泛实践。但是,目前肿瘤临床试验伦理审查互认仍存在一些问题,例如缺乏统一的伦理审查标准、伦理审查人员培训不足、伦理审查信息共享平台建设滞后等。基于此,本文提出以下建议:建立统一的伦理审查标准,规范审查程序;加强伦理审查人员培训,提高伦理审查水平;建立审查信息共享平台,实现资源共享和互认。
Oncology clinical trial is an important means for new drug development and treatment evaluation,and ethical review is an important step to protect the rights and safety of subjects.Therefore,establishing a mutual recognition mechanism for the ethical review of clinical trials of tumors has important practical significance,which can improve the approval efficiency,reduce repeated reviews,reduce the ethical risks,and promote international cooperation.This study conducted a comprehensive analysis and summary of the development status of mutual recognition of ethical review of clinical trials of tumors at home and abroad through literature analysis and research.The results showed that the mutual recognition of ethical review of clinical trials of tumors has become an international consensus and has been widely practiced worldwide.However,there are still some problems in the mutual recognition of ethical review of clinical trials of tumors,such as the lack of unified ethical review standards,insufficient training of ethical review personnel,and the lagging construction of an information sharing platform for ethical review.Therefore,the following suggestions are proposed:establish unified ethical review standards,standardize ethical review procedures;strengthen the training of ethical review personnel,improve the level of ethical review;establish an information sharing platform for ethical review to achieve resource sharing and mutual recognition.
作者
王雨萌
周铭
阎昭
WANG Yumeng;ZHOU Ming;YAN Zhao(The Medical Ethics Committee of China Anti Cancer Association;The Further Education and Science and Technology Service Department of China Anti Cancer Association)
出处
《中国癌症防治杂志》
CAS
2024年第2期152-157,共6页
CHINESE JOURNAL OF ONCOLOGY PREVENTION AND TREATMENT
关键词
肿瘤临床试验
伦理审查
互认机制
Clinical trials of tumors
Ethical review
Mutual recognition
