Patient recruitment: US perspective

Area of Science:

• Pediatric pharmacology
• Clinical trial management
• Bioethics

Background:

• Conducting drug trials in pediatric populations faces numerous ethical, legal, economic, scientific, and practical hurdles.
• Subject identification and enrollment, commonly known as recruitment, represent the most substantial obstacle in pediatric drug development.

Purpose of the Study:

• To review the multifaceted challenges inherent in the pediatric drug trial recruitment process.
• To propose actionable strategies and potential solutions for improving subject identification and enrollment in pediatric clinical trials.

Main Methods:

• Literature review of existing challenges in pediatric clinical trial recruitment.
• Analysis of ethical, legal, economic, and practical barriers to subject enrollment.
• Synthesis of proposed solutions and best practices for recruitment.

Main Results:

• Recruitment is identified as the primary difficulty in pediatric drug trials.
• Various factors contribute to recruitment challenges, including parental consent, disease prevalence, and trial complexity.
• Potential solutions involve community engagement, streamlined consent processes, and tailored recruitment approaches.

Conclusions:

• Addressing recruitment barriers is crucial for advancing pediatric drug development.
• Implementing proposed solutions can enhance the efficiency and success rate of pediatric clinical trials.
• Further research and collaboration are needed to optimize pediatric drug trial recruitment strategies.