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Pediatric Drug Development: Outlook for Science-Based Innovation.
Dionna J Green1, Issam Zineh1, Gilbert J Burckart1
1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clinical Pharmacology and Therapeutics
|February 1, 2018
Summary
Pediatric drug development has advanced significantly, with over 1,200 studies submitted to the US Food and Drug Administration (FDA) and improved trial success rates. This progress enhances the availability of safe and effective medications for children.
Area of Science:
- Pharmacology
- Pediatrics
- Clinical Trials
Background:
- Pediatric drug development has historically lagged behind adult drug development.
- There was a need for more robust data and regulatory frameworks to support medication use in children.
Purpose of the Study:
- To evaluate the progress and outcomes of pediatric drug development over the last 15 years.
- To assess the impact of new initiatives and networks on pediatric clinical trials.
Main Methods:
- Analysis of data submitted to the US Food and Drug Administration (FDA) from pediatric studies.
- Review of changes in drug labeling for pediatric use.
- Examination of the establishment and function of international pediatric trial networks.
- Comparison of pediatric efficacy trial failure rates over time.
Main Results:
- Over 1,200 pediatric studies have been submitted to the FDA.
- More than 700 drug labels have been updated with pediatric information.
- Two international pediatric trial networks are now operational.
- The failure rate in pediatric efficacy trials has decreased from over 40% to approximately 20%.
Conclusions:
- Significant advancements have been made in pediatric drug development.
- The establishment of networks and regulatory improvements have positively impacted trial success.
- The outlook for developing new and improved medications for pediatric populations is optimistic.
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