隨著我國創(chuàng)新藥物研發(fā)能力的不斷提高，新藥臨床試驗的數(shù)量也在不斷增加。新藥臨床試驗是驗證藥品有效性和安全性的關(guān)鍵環(huán)節(jié)，其結(jié)果的可靠性直接關(guān)系到百姓的用藥安全。臨床試驗的完成質(zhì)量受多方因素的影響，其中臨床試驗機(jī)構(gòu)的管理起重要的作用。通過分析藥物臨床試驗各環(huán)節(jié)的質(zhì)量風(fēng)險因素，并探討了降低風(fēng)險的應(yīng)對措施，以期為藥物臨床試驗的質(zhì)量管理以及項目質(zhì)量的提升提供借鑒。

With the continuous improvement of the development capacity of innovative drugs in China, the number of new drug clinical trials is also increasing. New drug clinical trial is the key link in the verification for efficiency and safety of drugs. Also, the result of drug clinical trials is directly related to the safety of medicines. The completion quality of clinical trials is affected by many factors, in which the quality management of drug clinical trials institution plays an important role. In this article, through analyzing the quality risk in each link of drug clinical trials, we hope to provide reference for quality management and the improvement of the project quality.