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Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.
Green, Dionna J; Liu, Xiaomei I; Hua, Tianyi; Burnham, Janelle M; Schuck, Robert; Pacanowski, Michael; Yao, Lynne; McCune, Susan K; Burckart, Gilbert J; Zineh, Issam.
Afiliación
  • Green DJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Liu XI; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Hua T; University of Michigan College of Pharmacy, Ann Arbor, Michigan, USA.
  • Burnham JM; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Schuck R; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Pacanowski M; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Yao L; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver, Spring, Maryland, USA.
  • McCune SK; Office of Pediatric Therapeutics, Commissioner's Office, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zineh I; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther ; 104(5): 983-988, 2018 11.
Article en En | MEDLINE | ID: mdl-29218740
Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in pediatric trials submitted to the US Food and Drug Administration from 2012-2016. In all, 112 efficacy studies associated with 76 drug development programs were assessed and their overall success rates were 78% and 75%, respectively. Eighty-eight trials (76.8%) employed at least one enrichment strategy; of these, 66.3% employed multiple enrichment strategies. The highest trial success rates were achieved when all three enrichment strategies (practical, predictive, and prognostic) were used together within a single trial (87.5%), while the lowest success rate was observed when no enrichment strategy was used (65.4%). The use of enrichment strategies in pediatric trials was found to be associated with trial and program success in our analysis.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Aprobación de Drogas / Selección de Paciente / Sujetos de Investigación / Desarrollo de Medicamentos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Aprobación de Drogas / Selección de Paciente / Sujetos de Investigación / Desarrollo de Medicamentos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos