摘要
一个科学、规范、具有可行性的试验设计是获得可靠数据与保障临床试验质量的基础.本文通过收集和整理一家药物临床试验机构承接的注册类中药品种临床试验资料,归纳分析试验设计中存在的问题,将纳入分析的18 项中药临床试验审查中发现的问题汇总分类为不符合法规要求、方案内容描述不清晰、试验方案和病例报告表等试验文件设计的可行性差、试验操作要求在不同研究文件或同一文件前后不一致、行文错误、其他等6 类.针对以上问题,探讨申办者、研究者、临床试验机构三方为保障设计质量可以采取的措施,以期为提高临床试验质量提供参考.
Abstract
A scientific,standardized,and feasible trial design is the basis for obtaining reliable data and guaranteeing the quality of clinical trials.In this study,the authors gathered and organized the information of clinical trials of registered traditional Chinese medicines varieties undertaken by a drug clinical trial institution,summarized and analyzed the issues in the clinical trial design.The issues found in the review of 18 clinical trials of traditional Chinese medicine were summarized and classified into six categories:non-compliance with regulatory requirements,unclear description of protocol content,poor feasibility of design of clinical trial documents such as trial protocol and case report form,inconsistent operation requirements before and after different research documents or the same document,writing errors,and others.In view of the above problems,the authors put forward the countermeasures that can be taken by the sponsor,investigator,and clinical trial institution to ensure the quality of the design,in order to provide reference for improving the quality of clinical trials.
基金项目
中国中医科学院科技创新工程项目(CI2021A04704)
NETL
NSTL
万方数据