Research
The Clinical & Translational Research Program for Pediatric (CTRPP) builds upon the foundation established by the Emory and MSM Departments of Pediatrics (DOPs) and Children's Healthcare of Atlanta (Children's). This is an unique and innovative partnership that allows ACTSI institutions to begin with translational research in a variety of therapeutic areas, multi-center clinical trials and extend to community-based research projects. Collaboration across disciplines, as well as, institutions has greatly increased. The ACTSI helped to enhance these collaborations and build strong working relationships between institutions, as well as, between basic and clinical sciences. By lowering these barriers, the CTRPP encourages and enables creative and innovative approaches in solving medical problems, catalyzing change, training the next generation of translational and clinical scientists focused on pediatric health, and effecting change in the community.
Children's and Emory Pediatric Research Centers of Excellence
As part of Children’s initiative to increase pediatric research, Children’s developed the Pediatric Research Centers (PRCs) in collaboration with Emory and Georgia Tech that are open to all investigators at ACTSI CTRPP partner institutions, including MSM. These include:
- AFLAC Cancer Center & Blood Disorders Service
- Center for Cystic Fibrosis Research
- Center for Developmental Lung Biology
- Center for Endothelial Biology
- Center for Immunology & Vaccines
- Center for Cardiovascular Biology
- Center for Transplant Immunology & Immune Therapeutics
- Center for Outcomes Research and Public Health
- Center for Pediatric Healthcare Technology Innovation
- Center for Drug Discovery
- Center for Pediatric Nanomedicine
- Marcus Autism Center
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Centralized Children’s Research Office
CTRPP established an integrated process for pre-award approval and post-award management of grants and other research proposals involving Emory pediatric faculty who conducted research activities in Children’s facilities. Furthermore, Children's and the CTRPP Program Committee re-organized the Children’s Research Office. Subsequently, an integration of the Emory Department of Pediatrics and Children’s Research Office continued with the cross-training of staff from both offices on respective institutional procedures. This was facilitated by relocation of the Children’s Research Office from the Tullie Office Park to office space within the Marcus Autism Center building adjacent to the Emory campus. The Children’s Research Office now reviews and manages subcontracts between Georgia Tech and Children’s medical staff, and assists with collaborative grants involving Georgia Tech and Emory pediatric faculty.
Office of Clinical Studies Research
The OCR provides the oversight and support necessary to assure ethical and safe conduct of clinical and translational investigation in children in conjunction with the Office for Clinical Research at Children's. Development of protocols, manual of operations, and training modules are overseen to ensure fidelity, consistency and reliability in the conduct of pediatric clinical studies. The OCR in conjunction with the ACTSI and CTRPP, with input from Children's, assumes primary responsibility for the development of these documents and provides training modules and tracks required research education. The OCR through the Regulatory, Safety and Quality Assurance Directors disseminates standard operating procedures, protocols and modules to appropriate members of the CTRPP. Investigators and staff are certified through the OCR in order to participate in pediatric studies.
Standardization and Training
All pediatric research studies conducted by the CTRPP follow exacting standards for delivering the interventions and collecting the requisite data. Prior to initiating any study nurse managers, lab managers and program director assure training sessions to teach the various aspects of the study procedures and make sure that they are applied consistently across staff and clinical centers and over time.
Safeguarding Participant Safety and Patient Rights
All study protocols must be approved by the Emory and/or MSM Internal Review Boards (IRBs) as appropriate. Special reporting procedures have been developed for serious and adverse experiences. All serious adverse events are reported promptly to the IRB, and information disseminated to the appropriate parties. The pediatric research subject advocate RSA with support from the Research Safety Section assist in convening pediatric data safety monitoring plans (DSMPs) and writing data safety monitoring board DSMB charters, as well as relating to outside DSMBs.
Informed Consent Process
Through participation in a variety of NIH-sponsored pediatric networks (Neonatal Research Network, Stillbirth Collaborative Research Network, Sickle Cell Disease Clinical Research Consortium, Halt PKD Network, Center for AIDS Research, Focal Glomerular Segmental Sclerosis Network, Transfusion Medicine Hemostasis Network, Childrens Oncology Group), in conjunction with the Research Safety Section and Section of Ethics in Research and Participant Advocacy (SERPA), the CTRPP evaluates different approaches to informed consent in pediatric and neonatal clinical trials.
Statistical Approaches
Through the Biostatistics, Epidemiology, & Research Design program within the ACTSI and current biostatistical support through Children's, CTRPP statistics is led by multiple PhD level faculty statisticians with experience in pediatric and special subjects studies.
Processing Laboratory and Biobanking Services
The Translational Technology & Resources program and the Clinical Interaction Network are essential for consistent and reproducible laboratory analysis. Through Laboratory Information Management System (LIMS), management for receiving, logging, tracking, reporting and returning test recordings; training for laboratory processing and ongoing training of laboratory personnel, processes for high quality sample acquisition will be established.
Allocation of Resources/Scientific Review
Review of pediatrics proposals is performed by a Pediatrics Scientific Research Committee (PSRC), similar to the procedure described in the Clinical Interaction Network program