title: Pediatric registries at the Food and Drug Administration: design aspects that increase their likelihood of success.
abstract: To determine aspects of the design of pediatric registries that contribute to the success of registries conducted as a postmarketing study following approval of drugs or biological products by the US Food and Drug Administration.
  
  
  
  Pediatric registries for drugs and biological products were identified by searching the US Food and Drug Administration Postmarketing Requirements and Commitments database. Based on the recruitment of patients, the meeting of predetermined deadlines, and the submission of data, we classified studies as successful, unsuccessful, or unevaluable. Design aspects of successful and unsuccessful registries were examined for commonalities.
  
  
  
  Thirty-eight studies were identified, and ten registries met the criteria for successful. Four (40%) successful registries utilized a registry established prior to product approval, and six (60%) were disease-based. Among unsuccessful registries, none were disease-based or utilized a pre-existing registry.
  
  
  
  Characteristics identified as more common to successful registries included utilizing a disease-based registry and a registry established prior to product approval. Future studies might examine a larger sample of registries to see if these aspects consistently result in successful studies. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.
authors.affiliation: Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Scott K
authors.initials: SK
authors.lastname: Winiecki
authors.affiliation: Division of Manufacturing and Quality, Office of Compliance, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: M Isabel
authors.initials: MI
authors.lastname: Tejero-Taldo
authors.affiliation: Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Debbie
authors.initials: D
authors.lastname: Avant
authors.affiliation: Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Dianne
authors.initials: D
authors.lastname: Murphy
authors.affiliation: Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Ann W
authors.initials: AW
authors.lastname: McMahon
mesh_terms: D001688:Biological Products / Q000009:adverse effects; D002648:Child; D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products
keywords: US Food and Drug Administration; pediatrics; pharmacoepidemiology; postmarketing; product surveillance; registries