U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Projections Research Inc, Phoenixville, Pennsylvania, USA.
Clin Pharmacol Ther. 2018 Jul;104(1):81-87. doi: 10.1002/cpt.975. Epub 2018 Jan 10.
This article discusses the use of big data in pediatric drug development. The article covers key topics discussed at the ACCP annual meeting symposium in 2016 including the extent to which big data or real-world data can inform clinical trial design and substitute for efficacy and safety data typically obtained in clinical trials. The current states of use, opportunities, and challenges with the use of big data in future pediatric drug development are discussed.
本文讨论了大数据在儿科药物开发中的应用。本文涵盖了 2016 年 ACCP 年会研讨会讨论的关键主题，包括大数据或真实世界数据在多大程度上可以为临床试验设计提供信息，并替代通常在临床试验中获得的疗效和安全性数据。讨论了大数据在未来儿科药物开发中的使用现状、机遇和挑战。
