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Pediatric versus adult drug trials for conditions with high pediatric disease burden

Florence T Bourgeois1, Srinivas Murthy, Catia Pinto

  • 1Division of Emergency Medicine, Children's Hospital Boston, 300 Longwood Ave, Boston, MA 02115, USA. florence.bourgeois@childrens.harvard.edu

Pediatrics
|July 25, 2012
PubMed

Insights

Pediatric drug trials are underrepresented compared to childhood disease burden, with fewer trials focusing on safety. Funding sources also differ, with pediatric studies relying more on government and nonprofit support.

Area of Science:

  • Clinical pharmacology
  • Pediatric research
  • Drug development

Background:

  • Optimal pediatric treatment requires robust safety and efficacy data.
  • Concerns exist regarding the underrepresentation and distinct nature of pediatric clinical drug trials compared to adult trials.

Purpose of the Study:

  • To quantify the prevalence of pediatric studies within clinical drug trials.
  • To compare the characteristics and quality indicators of pediatric versus adult drug trials.

Main Methods:

  • Analysis of drug trials registered in ClinicalTrials.gov (2006-2011) for high pediatric disease burden conditions.
  • Comparison of trial proportions, subject allocation, characteristics, and quality indicators between pediatric and adult trials.

Main Results:

  • Children bear 59.9% of the disease burden, yet only 12.0% of trials were pediatric.
  • Pediatric trials were less likely to be industry-funded (58.6% vs 35.0%) and focused less on safety outcomes (10.1% vs 16.9%).
  • Pediatric trials showed slightly better registration practices and publication rates.

Conclusions:

  • A significant gap exists between the pediatric disease burden and dedicated clinical trial research.
  • Funding sources, primarily government and nonprofit for pediatric trials, may influence research focus and prevalence.
Abstract

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