Planning for pediatric asset development is critical to the success of drugs reaching the market in a timely fashion. However, designing and conducting pediatric research involves more than simply repurposing the protocol for a drug targeted to adults. Clinical studies aimed at children pose specific recruitment, ethical, scientific, logistical and labeling challenges that demand the expertise of those dedicated to pediatric research.
Here we review the regulatory requirements pertaining to pediatric research, highlight the challenges developers face in devising appropriate study designs and describe some innovative solutions for meeting those challenges.
