[關(guān)鍵詞]
[摘要]
通過(guò)查閱英國(guó)藥物臨床試驗(yàn)法律法規(guī)、指南、相關(guān)文獻(xiàn),并對(duì)歷年績(jī)效數(shù)據(jù)進(jìn)行統(tǒng)計(jì)后發(fā)現(xiàn),英國(guó)藥物臨床試驗(yàn)審評(píng)時(shí)限比較注重科學(xué)性和靈活性,對(duì)技術(shù)審評(píng)與倫理審查程序采取并行的安排,并建立了上市后臨床研究和研究者發(fā)起的科研性臨床研究的審查機(jī)制等內(nèi)容值得我國(guó)借鑒。我國(guó)現(xiàn)行藥物臨床試驗(yàn)管理制度,較好地保證了受試者的安全,但仍要把握對(duì)臨床試驗(yàn)制度要素的控制,不僅在程序上要層層把關(guān),還要盡可能提高審查的效率,使新的療效好的藥物盡快在我國(guó)上市,以滿(mǎn)足我國(guó)人民的用藥需求。
[Key word]
[Abstract]
After reviewing the laws and regulations, guidelines, and related literatures on clinical trials of drugs in the United Kingdom, and statistics of performance data over the years, it is found that the review time limit for clinical trials of drugs in the United Kingdom pays more attention to scientificity and flexibility, and the technical review and ethical review procedures are parallel. The arrangement and establishment of post-marketing clinical research and the review mechanism of scientific research clinical research initiated by researchers are worthy of reference for our country. Current drug clinical trial management system in China has better ensure the safety of subjects, but it is still necessary to control the elements of the clinical trial system. Not only the procedures must be checked at all levels, but the efficiency of the review must be improved as much as possible, so that new drugs with good curative effects will be put on the market in China as soon as possible to meet the needs of the Chinese people.
[中圖分類(lèi)號(hào)]
R288
[基金項(xiàng)目]