论文总字数：14882字

摘 要

目前，我国在逐步完善对药物临床试验的管理，但法规对试验质量控制的具体内容、形式均无细节要求，因此试验质量与国际标准存在较大的差距。所以提高I期药物临床试验的质量对于药物研究有非常重要的意义。

本文将讨论I期临床试验的现状，如I期试验知情同意签署违规现象频出；健康受试者筛选成功率低；试验过程信息化手段落后；数据清理规范性差以及研究护士临床意识薄弱。分析现状原因有几方面，I期药物研究的质量控制手段不完善；试验过程未完全遵守GCP实施；不尊重受试者导致依从性低，受试者病例填写不规范完整。探讨I期试验质量现状的解决对策，如加强GCP培训，提高研究人员的责任意识；保护受试者安全，尊重权益；试验资料信息化管理以及采取措施增多试验过程中的控制环节。希望这些举措对提高I期试验质量有所帮助。

关键词：新药研究；现状原因；全过程质量控制；对策建议；

A brief analysis of the quality control from phase I clinical trial screening to data cleaning

Abstract

At present,China is gradually improving the management of drug clinical trials,but relevant laws and regulations have no detailed requirements on the specific content and form of test quality control,so there is still a large gap between the test quality and international standards.Therefore,improving the quality of phase I drug clinical trials is of great significance for drug research.

This paper will discuss the current situation of I phase clinical trials, such as the frequent occurrence of informed consent signing irregularities in the phase I trial; the low success rate of screening of healthy subjects; the backward information means in the trial process; the poor standardization of data cleaning and the weak clinical consciousness of research nurses. There are several reasons for the analysis of the current situation, the quality control means of the drug research in the I stage are not perfect; the test process is not fully complied with GCP implemented; the failure to respect the subjects leads to low compliance, and the case filling of the subjects is not standardized and incomplete. To explore the solution of the present situation of the quality of the I trial, such as strengthening the GCP training, raising the sense of responsibility of the researchers; protecting the safety of the subjects and respecting their rights and interests; and the experiment data information management and measures to increase the control of the test process. I hope that these initiatives will help to improve the quality of I trial.

Keywords:New drug research; Current reason; Total quality control; Countermeasures and suggestions;

目录

摘要 I

Abstract II

第一章 绪论 1

1.1 研究的背景 1

1.2 研究的重要性 2

1.3 研究的意义 2

2.1 I期药物临床试验的基本情况简介 3

2.2 I期药物临床试验筛选期到数据清理阶段的关键因素 3

2.2.1 药物I期临床筛选期 3

2.2.2 药物I期临床试验期方案偏离频率 4

2.2.3 药物I期临床数据清理阶段数据记录的及时、真实和完整 4

第三章 我国I期临床试验筛选期到数据清理质量控制的现状 5

3.1 我国I期临床试验筛选期知情同意签署违规现象频出 5

3.2 我国I期受试者筛选成功率低 6

3.3 我国I期临床试验过程中信息化手段滞后 6

3.4 我国I期临床试验数据清理阶段数据的规范性较差 7

3.5 研究护士临床意识薄弱 8

第四章 I期药物临床试验的质量控制措施 9

4.1 规范知情同意过程 9

4.2 尊重受试者并提高依从性 9

4.3 加强研究人员GCP、SOP培训 9

4.4 提高信息化管理 10

4.5 加强质量保障体系的建设 10

第五章 案例分析 11

5.1具体案例分析 11

小结与展望 13

致谢 14

参考文献 15

第一章 绪论

1.1 研究的背景

随着我国药物临床试验迅速发展，专业的试验机构的需求量也在增大。如图1.1截止2013年底403家药物临床试验机构在各省份的分布情况^[16]，数据显示东部地区由于发达的经济、较完善的卫生资源配置，临床试验发展趋势更好。

图1.1 各省份获得认定的药物临床试验机构数量

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