Principal Investigator/Program Director (Last, first, middle): Ross, Judith, M.D. Historically, there have been barriers to involvement of many children in the U.S. in state-of-the art pediatricclinical trials. The IDeA States Pediatric Clinical Trials Network (ISPCTN) represents a transformationalopportunity to recruit more underserved children to participate in state-of-the-art clinical trials, facilitateimplementation of well-designed pediatric clinical trials, and enhance pediatric clinical trial capacity within theIDeA state, Delaware (DE) at Nemours/Alfred I duPont Hospital for Children (AIDHC). The creation of the DENemours/AIDHC ISPCTN site will harness current key resources in the hospital and the community includingDE pediatrics practice-based networks that cover over 65,000 children, access to historically underrepresentedpediatric populations in DE, and robust community engagement programs such as the Nemours children'shealth website KidsHealth. We have the human talent with highly experienced clinical research teams(investigators, coordinators, study recruiters, data entry staff), and the clinical research infrastructure (Clinicalresearch center, IRB processes, standard operating procedures). Nemours/AIDHC has >15 years' experiencewith system-wide use of electronic medical records (EPIC). The DE-Nemours/AIDHC ISPCTN site willsynergize with ongoing DE IDeA state clinical research resources including the Delaware Clinical andTranslational Research ACCEL Program (DE-CTR), the Delaware IDeA Network of Biomedical ResearchExcellence (INBRE) program, and the Nemours Delaware IDeA Centers of Biomedical Research Excellence(COBRE) programs that are focused on pediatrics (Center for Pediatric Research). In this application, wedemonstrate how our strengths in community engagement/patient recruitment, clinical research expertise, andinfrastructure have allowed us to engage in clinical trials research in the four focus areas in the Environmentalinfluences on Child Health Outcomes (ECHO) Program including Upper and lower airway disorders, Obesity,Pre-/Peri-/Postnatal outcomes, and Neurodevelopment. The DE-Nemours/ AIDHC ISPCTN site will workclosely with the ISPCTN Data Coordinating and Operations Center in terms of development and implement-ation of ISPCTN clinical trials, study design, recruitment and implementation, and data management.
The Specific Aims are to:
Aim 1 : Increase participation of diverse/underserved pediatric populations inclinical trials within DE and across IDeA states, Aim 2: Provide the clinical research expertise (qualifiedinvestigators, coordinators, study recruiters, data entry staff) for the DE-Nemours/AIDHC ISPCTN site, andAim 3: Promote the infrastructure hub for conducting pediatric clinical trials at the DE-Nemours/AIDHC site. The DE-Nemours/AIDHC site participation in the ISPCTN will catalyze new ideas, promote new collabora-tions, and will engage clinicians, researchers, and the community in well-designed pediatric clinical trials.Provision of this expertise and infrastructure will increase cutting edge clinical trial research with improvedefficiencies for initiating and completing clinical trials and improved public health in DE and the nation.PHS 398/2590 (Rev. 05/01) Page _______ Continuation Format Page
; first; middle): Ross; Judith; M.D.Historically; there have been barriers to involvement of many children in the U.S. in state-of-the art pediatricclinical trials. The IDeA States Pediatric Clinical Trials Network (ISPCTN) represents a transformationalopportunity to recruit more underserved children to participate in state-of-the-art clinical trials; facilitateimplementation of well-designed pediatric clinical trials; and enhance pediatric clinical trial capacity within theIDeA state; Delaware (DE) at Nemours/Alfred I duPont Hospital for Children (AIDHC). The DE-Nemours/AIDHC site participation in the ISPCTN will catalyze new ideas; promote new collaborations; and willengage clinicians; researchers; and the community in well-designed pediatric clinical trials. Provision of thisexpertise and infrastructure will increase cutting edge clinical trial research with improved efficiencies forinitiating and completing clinical trials and improved public health in DE and the nation.PHS 398/2590 (Rev. 05/01) Page _______ Continuation Format Page
| Snowden, Jessica; Darden, Paul; Palumbo, Paul et al. (2018) The institutional development award states pediatric clinical trials network: building research capacity among the rural and medically underserved. Curr Opin Pediatr 30:297-302 |
