Clin Pharmacol Ther 2018 07 10;104(1):81-87. Epub 2018 Jan 10.
Sanofi, Bridgewater, New Jersey, USA.
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.