| 关于临床试验经费管理的思考及实践 |
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| 引用本文： | 汤洁,胡薏慧,彭朋,元唯安. 关于临床试验经费管理的思考及实践[J]. 现代药物与临床, 2019, 42(12): 2492-2496 |
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| 作者姓名： | 汤洁 胡薏慧 彭朋 元唯安 |
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| 作者单位： | 上海中医药大学附属曙光医院 国家药物临床试验机构, 上海 201203,上海中医药大学附属曙光医院 国家药物临床试验机构, 上海 201203,上海中医药大学附属曙光医院 国家药物临床试验机构, 上海 201203,上海中医药大学附属曙光医院 国家药物临床试验机构, 上海 201203 |
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| 基金项目： | “十三五”重大新药创制项目（2017ZX09304002） |
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| 摘 要： | 临床试验经费管理的水平影响临床试验的质量。分析临床试验经费管理的现状以及影响临床试验经费管理的因素，提出针对性的改进措施。目前，临床试验经费收入性质不明、管理标准不一、预算编制粗犷、劳务分配不均、审批效率低下等是影响临床试验经费管理水平的主要因素，通过完善各项制度、细化经费编制、明确分配标准、加强成本核算、共建信息平台等方法提高经费管理的水平，进而提高临床试验的质量，加速药物临床评价。
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| 关 键 词： | 临床试验 药物临床评价 经费管理 |
| 收稿时间： | 2019-06-24 |
Reflections and practices of clinical trial fund management |
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| TANG Jie,HU Yihui,PENG Peng and YUAN Wei''an. Reflections and practices of clinical trial fund management[J]. Drugs & Clinic, 2019, 42(12): 2492-2496 |
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| Authors: | TANG Jie HU Yihui PENG Peng YUAN Wei''an |
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| Affiliation: | National Drug Clinical Trial Institution, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China,National Drug Clinical Trial Institution, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China,National Drug Clinical Trial Institution, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China and National Drug Clinical Trial Institution, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China |
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| Abstract: | The level of clinical trial funding management influences the quality of clinical trial. This paper analyzes the current situation of the fund management of clinical trials and the factors influencing the fund management of clinical trials, and puts forward some corresponding improvement measures. The non-transparency of clinical trial funds use, management criteria disparities, imprecise budget, unreasonable labor assignment, and ineffectiveness of approval are the main factors affecting the management level of clinical trial funds. To improve the quality of clinical trials and accelerate the clinical evaluation of drugs, we should improve the management level of funds by perfecting the system, detailing the outlay, defining the distribution standard, strengthening the cost accounting and building the information platform. |
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| Keywords: | pharmacy clinical test drug clinical trial funding management |
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