New England Journal of Medicine
June 7, 2018 Vol. 378 No. 23
Assessing Drug Safety in Children — The Role of Real-World Data
Ann W. McMahon, M.D.,
and Gerald Dal Pan, M.D., M.H.S.
There are substantial gaps in evidence regarding the safety of many drugs in children. Increasingly, studies assessing drug safety can incorporate data obtained in the course of clinical care to generate real-world evidence and help fill these gaps.