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Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective

Andrew E Mulberg1, Timothy Cripps1

  • 1Amicus Therapeutics Inc, Cranbury, NJ.

Current Therapeutic Research, Clinical and Experimental
|August 8, 2019
PubMed

Insights

Industry-sponsored studies in Slovenia raise concerns about pediatric data. This highlights the need for improved legislative measures in the US and EU to ensure accurate drug dosing information for children.

Area of Science:

  • Pediatric clinical pharmacology
  • Regulatory science
  • Bioethics

Background:

  • Industry-sponsored research in pediatric populations is critical for drug safety and efficacy.
  • Concerns exist regarding the quality and transparency of pediatric clinical trials.
  • Slovenia serves as a case study to examine these issues.

Purpose of the Study:

  • To analyze industry-sponsored studies involving children and adolescents in Slovenia.
  • To discuss the implications for pediatric drug data and labeling.
  • To evaluate current and evolving legislative frameworks in the US and EU.

Main Methods:

  • Review of existing literature on pediatric clinical trials.
  • Analysis of legislative documents from the US and EU.
  • Case study approach focusing on Slovenian research.

Main Results:

  • Identification of questionable practices in industry-sponsored pediatric studies.
  • Discussion of legislative gaps and advancements in pediatric trial regulations.
  • Emphasis on the need for enhanced data for pediatric drug dosing.

Conclusions:

  • Improved legislative measures are essential for robust pediatric clinical trial data.
  • Clearer and more coherent drug labeling is crucial for pediatric healthcare providers.
  • International collaboration is needed to ensure the ethical and scientific integrity of pediatric research.

Keywords:
BPCAPIPPREAPediatric drug development

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