The majority of drugs administered to children are used off label and PK studies to define appropriate dosing are lacking across pediatric age groups. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard of care procedures have proven successful in characterizing the PK of drugs used in children. The purpose of this study is to characterize the PK of understudied drugs administered to children per standard of care as prescribed by their treating caregiver.
This study will serve as a tool to better understand drug exposure in children receiving drugs per standard of care. The data collected through this initiative will provide valuable PK and dosing information drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
TrialNet is a large network of clinical sites established by the NIH to conduct research studies to prevent and/or delay onset of Type 1 Diabetes. The coordinated efforts of the TrialNet centers is through George Washington University.
The goals of the TrialNet Natural History Study of the Development of Type 1 Diabetes are to both gain information about the pathogenesis and natural history of Type 1 Diabetes and to facilitate the recruitment and assessment of individuals who might qualify for future Type 1 Diabetes prevention trials. Importantly, the information obtained from this study is anticipated to enable the development and implementation of future diabetes prevention trials.
The TrailNet Natural History Study of the Development of Type 1 Diabetes is divided into three phases: Screening (Phase 1), Baseline Risk Assessment (Phase 2) and Follow-up Risk Assessments (Phase 3).