Four dimensions of receiving overseas clinical trial data about drug and medical devices
10.12092/j.issn.1009-2501.2020.07.018
- VernacularTitle: 论接受药品医疗器械境外临床试验数据的四个维度
- Author:
Haihong JIANG
1
Author Information
1. School of Medical Instrument Shanghai University of Medical & Health Science
- Publication Type:Journal Article
- Keywords:
Drugs;
Medical devices;
Overseas clinical trials;
Quality of data management
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(7):835-840
- CountryChina
- Language:Chinese
-
Abstract:
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.
