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 pediatric clinical trials. The IDeA States Pediatric Clinical Trials Network (ISPCTN) represents a transformational opportunity to recruit more underserved children to participate in state-of-the-art clinical trials, facilitate implementation of well-designed pediatric clinical trials, and enhance pediatric clinical trial capacity within the IDeA state, Delaware (DE) at Nemours/Alfred I duPont Hospital for Children (AIDHC). The creation of the DE Nemours/AIDHC ISPCTN site will harness current key resources in the hospital and the community including DE pediatrics practice-based networks that cover over 65,000 children, access to historically underrepresented pediatric populations in DE, and robust community engagement programs such as the Nemours children's health 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 (Clinical research center, IRB processes, standard operating procedures). Nemours/AIDHC has >15 years' experience with system-wide use of electronic medical records (EPIC). The DE-Nemours/AIDHC ISPCTN site will synergize with ongoing DE IDeA state clinical research resources including the Delaware Clinical and Translational Research ACCEL Program (DE-CTR), the Delaware IDeA Network of Biomedical Research Excellence (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, we demonstrate how our strengths in community engagement/patient recruitment, clinical research expertise, and infrastructure have allowed us to engage in clinical trials research in the four focus areas in the Environmental influences 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 work closely 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 in clinical trials within DE and across IDeA states, Aim 2: Provide the clinical research expertise (qualified investigators, coordinators, study recruiters, data entry staff) for the DE-Nemours/AIDHC ISPCTN site, and Aim 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 improved efficiencies 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
Ross, Judith, M.D. Historically, there have been barriers to involvement of many children in the U.S. in state-of-the art pediatric clinical trials. The IDeA States Pediatric Clinical Trials Network (ISPCTN) represents a transformational opportunity to recruit more underserved children to participate in state-of-the-art clinical trials, facilitate implementation of well-designed pediatric clinical trials, and enhance pediatric clinical trial capacity within the IDeA 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 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 improved efficiencies 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
