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Significant delays exist in industry-sponsored pediatric clinical drug trial start-up and enrollment processes

Angie Price1, Hannah Simmons2, Emily Gehring3

  • 1Institute for Advanced Clinical Trials for Children, Rockville, MD, United States of America.

Contemporary Clinical Trials
|September 26, 2024
PubMed

Insights

Pediatric drug development faces significant clinical trial start-up delays, impacting the approval of new therapies for children. Addressing these delays is crucial for advancing pediatric medicine.

Area of Science:

  • Pediatric Clinical Trials
  • Drug Development
  • Regulatory Science

Background:

  • Pediatric drug development faces persistent challenges despite incentives.
  • There is a critical need to optimize clinical trial processes for pediatric therapeutics.

Purpose of the Study:

  • To measure and identify delays in the pediatric clinical trial process.
  • To assess timelines across multiple sites and study phases.

Main Methods:

  • The Pediatric Improvement Collaborative for Clinical Trials & Research prospectively monitored 16 time points.
  • Data were collected from 330 industry-sponsored pediatric drug studies across 24 sites.

Main Results:

  • Average time to final budget approval: 121 days (range 3-585).
  • Average time to Institutional Review Board (IRB) approval: 51 days (range 1-205).
  • Average time to first patient consented: 239 days (range 30-534).

Conclusions:

  • Significant start-up delays were observed in industry-sponsored pediatric clinical drug trials.
  • Variability across all study phases highlights numerous areas for process improvement.
Abstract

Keywords:
Clinical trialsMetricsNetworksPediatrics

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