[關(guān)鍵詞]
[摘要]
臨床試驗經(jīng)費管理的水平影響臨床試驗的質(zhì)量。分析臨床試驗經(jīng)費管理的現(xiàn)狀以及影響臨床試驗經(jīng)費管理的因素,提出針對性的改進措施。目前,臨床試驗經(jīng)費收入性質(zhì)不明、管理標(biāo)準(zhǔn)不一、預(yù)算編制粗獷、勞務(wù)分配不均、審批效率低下等是影響臨床試驗經(jīng)費管理水平的主要因素,通過完善各項制度、細化經(jīng)費編制、明確分配標(biāo)準(zhǔn)、加強成本核算、共建信息平臺等方法提高經(jīng)費管理的水平,進而提高臨床試驗的質(zhì)量,加速藥物臨床評價。
[Key word]
[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.
[中圖分類號]
[基金項目]
“十三五”重大新藥創(chuàng)制項目(2017ZX09304002)