藥物臨床試驗(yàn)作為新藥研發(fā)的關(guān)鍵環(huán)節(jié)，其實(shí)施質(zhì)量至關(guān)重要。目前，多數(shù)藥品研發(fā)企業(yè)采用與合同研究組織（CRO）合作的方式，將臨床試驗(yàn)項(xiàng)目外包。而在實(shí)際合作過程中，CRO在組織架構(gòu)、人員配備及管理、專業(yè)水平、項(xiàng)目質(zhì)量控制、與申辦方溝通等方面可能存在一定問題，從而導(dǎo)致臨床試驗(yàn)項(xiàng)目存在缺陷或失敗。為了降低研發(fā)風(fēng)險(xiǎn)，藥品研發(fā)企業(yè)應(yīng)選擇合適的CRO，同時(shí)建立質(zhì)量控制體系，對(duì)臨床試驗(yàn)項(xiàng)目的實(shí)施質(zhì)量及進(jìn)展進(jìn)行有效管理，確保臨床試驗(yàn)數(shù)據(jù)的真實(shí)性、完整性和準(zhǔn)確性。對(duì)藥物臨床試驗(yàn)項(xiàng)目外包的風(fēng)險(xiǎn)及管理策略進(jìn)行了闡述與分析，為藥物臨床試驗(yàn)外包的管理提供參考。

Drug clinical trials are a key link in drug development, and its quality is very important. In order to make effective use of resources, most drug R&D enterprises cooperate with CRO to outsource clinical trials. However,In the process of cooperation, CRO may have some problems in organizational structure, personnel management, professionalism, project quality control, communication and other aspects, which may lead to the failure of clinical trial projects. In order to reduce the risk, drug R&D companies should select the appropriate CRO and establish a quality control system, Manage projects well to ensure the authenticity, completeness and accuracy of clinical trial data.This paper analyzes the risk and management of drug clinical trial outsourcing.

R969.4

國(guó)家地方聯(lián)合工程研究中心項(xiàng)目（發(fā)改辦高技［2019］180號(hào)）；廣東省中藥破壁飲片工程實(shí)驗(yàn)室項(xiàng)目（粵發(fā)改創(chuàng)新函［2018］3149號(hào)）；中山市重大科技專項(xiàng)（科技強(qiáng)企計(jì)劃）項(xiàng)目（2018010308）