论接受药品医疗器械境外临床试验数据的四个维度

Four dimensions of receiving overseas clinical trial data about drug and medical devices

我国已经启动了药品医疗器械境外临床试验数据的接受工作,符合要求的境外数据可用于国内注册。要做好该工作,应该从数据接受原则性、数据质量可靠性、数据评价可用性和数据国际差异性等四个关键维度来加以考察。其中,数据的真实性、完整性、准确性以及可溯源性是决定数据质量可靠性的主要因素。接受药品医疗器械境外临床试验数据,将有利于临床试验数据国际互认制度的建立,并提升国内临床试验数据管理的重视程度,推动临床试验数据质量管理体系的形成。

China has started to accept the overseas clinical trial data about drug and medical devices,and the data in accordance with the requirements can be used to register in China.To do this work well,we should consider four key dimensions:data acceptance principle,data quality and reliability,data evaluation usability and data international difference.Among them,the authenticity,integrity,accuracy and traceability of data are the main factors to determine the quality reliability of data.Receiving data from overseas clinical trials about drug and medical devices will be conducive to the establishment of international mutual recognition system for clinical trial data,and to enhance the importance of data management in domestic clinical trials,and to promote the formation of quality management system on clinical trial data.