我国药物Ⅰ期临床试验受试者招募现状及策略研究

发布时间：2018-10-05 06:53

【摘要】：统计并分析北京大学第一医院2012年2月至2016年2月自主建立的Ⅰ期临床试验受试者数据库与2014年6月起参与受试者联网数据库后至2016年2月的筛选期数据,参考我院受试者招募工作模式,认为影响我国Ⅰ期临床试验受试者招募的因素主要包括试验方案、区域性竞争、受试者自身因素、试验机构因素等。分析受试者招募存在的问题主要包括受试者来源复杂、招募途经多样、招募广告不规范、伦理规范欠缺、第三方招募尚未规范、招募人数计算不准等。本文介绍我院两种数据库在筛选期的数据及可行性调查、制定计划、计算有效招募人数等核心工作模式,探讨合理招募受试者策略,以期提高Ⅰ期临床试验受试者招募效率与质量,保障试验进度与准确性。
[Abstract]:The phase I clinical trial subjects database established by the first Hospital of Peking University from February 2012 to February 2016 and the screening period data from June 2014 to February 2016 were statistically analyzed. Referring to the working mode of subjects recruitment in our hospital, it is considered that the main factors affecting the recruitment of subjects in phase I clinical trials in China include the trial scheme, regional competition, the subjects' own factors, the factors of the experimental organization, and so on. The main problems in the analysis of the subjects' recruitment include the complexity of the subjects' sources, the diversity of recruitment methods, the non-standard recruitment advertisements, the lack of ethical norms, the unstandardized recruitment of third parties, the inaccurate calculation of recruitment numbers, and so on. This paper introduces the data and feasibility investigation of the two kinds of databases in our hospital during the screening period, makes a plan, calculates the effective recruitment number and other core working modes, and probes into the rational strategy of recruiting subjects. In order to improve the efficiency and quality of stage I clinical trial subjects, ensure the progress and accuracy of the trial.
【作者单位】：北京大学第一医院药剂科;
【基金】：国家自然科学基金资助项目(81373487)
【分类号】：R969.4

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