Changes in Drug Development Regulations and Their Impact on Clinical Trials

  • Kevin D. HillEmail author
  • Rachel D. Török
  • Ronald J. Portman
  • Jennifer S. Li
Reference work entry


Regulatory changes in the United States and Europe have stimulated major pediatric clinical trials of over 15 different antihypertensive agents over the last two decades. With increased pediatric hypertension trial experience, trial designs have been refined, and we now better understand factors associated with trial success or failure. Appropriate dose range, weight-based dosing, use of a liquid formulation, and use of appropriate blood pressure endpoints are all factors that have been associated with improved trial success. These lessons learned and important modifications in trial design templates are reflected in the United States Food and Drug Administration Written Request criteria. The Written Request provides valuable information that can be used to optimally design future clinical trials of antihypertensive agents as well as other therapeutic agents for use in children.


Pediatric hypertension Clinical trials Written Request Pediatric exclusivity Trial design 


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Copyright information

© Springer International Publishing AG 2018

Authors and Affiliations

  • Kevin D. Hill
    • 1
    • 2
    Email author
  • Rachel D. Török
    • 1
  • Ronald J. Portman
    • 3
  • Jennifer S. Li
    • 1
    • 2
  1. 1.Department of PediatricsDuke Clinical Research InstituteDurhamUSA
  2. 2.Department of PediatricsDuke University Medical CenterDurhamUSA
  3. 3.Pediatric Therapeutic AreaNovartis Pharmaceutical CorporationEast HanoverUSA

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