Optimizing Enrollment in Pediatric Obese Patients: Reflections on Recruitment Characteristics

Clinical research involving children and adolescents with obesity is challenging due to recruitment, transportation barriers, parents/guardians working multiple jobs and the need to coordinate the schedule of the participant and the parent/guardian. We describe recruitment efforts and successes for a longitudinal observational study of adolescents with obesity

Optimizing Enrollment in Pediatric Obese Patients: Reflections on Recruitment Characteristics

Clinical research involving children and adolescents with obesity is challenging due to recruitment, transportation barriers, parents/guardians working multiple jobs and the need to coordinate the schedule of the participant and the parent/guardian. We describe recruitment efforts and successes for a longitudinal observational study of adolescents with obesity

Special Population Considerations and Regulatory Affairs for Clinical Research

Special populations, including women (non-pregnant and pregnant), pediatrics, and the elderly, require additional consideration with regard to clinical research. There are very specific regulatory laws, which protect these special populations, that need to be understood and adhered to in order to perform clinical research. This review provides a broad overview of some of the physiological differences in special populations and discusses how these differences may affect study design and regulatory considerations. These various special populations, with respect to regulatory affairs, are clearly defined within the Code of Federal Regulations. The definition of “special population” exists to provide enhanced awareness of their vulnerabilities, thereby allowing the creation of regulatory guidance aimed to decrease injury or outright harm. Currently, progress is being made to be more inclusive of special populations in clinical trials. This reflects changing attitudes towards drug information, with it being more representative of those patients that will ultimately be prescribed or exposed to the therapy. However, all research undertaken in these populations should be performed in a manner that ensures all protections of each participant are upheld