Real-World Evidence to Assess Medication Safety or Effectiveness in Children: Systematic Review

Author:

Lasky TamarORCID,Carleton Bruce,Horton Daniel B.,Kelly Lauren E.,Bennett Dimitri,Czaja Angela S.,Gifkins Dina,Osokogu Osemeke U.,McMahon Ann W.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical)

Reference76 articles.

1. US Congress. 21st Century Cures Act. HR 34, 114th Congress, enacted on Dec 13, 2016.

2. Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, et al. Real-world evidence—what is it and what can it tell us? N Engl J Med. 2016;375(23):2293–7. https://doi.org/10.1056/NEJMsb1609216.

3. Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act, Pediatric Research Equity Act, Board on Health Sciences Policy, Institute of Medicine. In: Field MJ, Boat TF, editors. Safe and effective medicines for children: pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Washington, DC: National Academies Press; 2012.

4. Frattarelli DA, Galinkin JL, Green TP, Johnson TD, Neville KA, Paul IM, et al. Off-label use of drugs in children. Pediatrics. 2014;133(3):563–7. https://doi.org/10.1542/peds.2013-4060.

5. Joseph PD, Craig JC, Caldwell PHY. Clinical trials in children. Br J Clin Pharmacol. 2015;79(3):357–69. https://doi.org/10.1111/bcp.12305.

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