Research
The Clinical and 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 (CHOA). 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 is expected. ACTSI plans to further 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, catalyze change, train the next generation of translational and clinical scientists focused on pediatric health, and effect change in the community.
Investigator Interface with CTRPP
In conjunction with the Office of Human Studies Research (OHSR) and Pediatric Clinical Research Office (PCRO), the CTRPP develops processes to streamline the research process for pediatric investigators in the ACTSI. A simple, one page form for entry into the system will trigger assignment of a Pediatric Research Navigator to the project. Communications with the investigator is initiated to facilitate aid for study design and implementation, and the navigator takes the lead in guiding the investigator through the regulatory process as outlined by CHOA, ORC, and OHSR.
Office of Clinical Studies Research
The ACTSI 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 CHOA. 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 CHOA, assumes primary responsibility for the development of these documents and provide training modules and track 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, the navigators, 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. Through the ACTSI Novel Electronic Research Record (NoERR), the CTRPP also assumes specific responsibility for the Electronic Data Capture system.
Safeguarding Participant Safety and Patient Rights
All study protocols must be approved by the Emory and/or MSM Internal Review Boards (IRBs) as appropriate. The OHSR Pediatrics Navigator have developed templates for informed consent forms and assent documents. Special reporting procedures have been developed for serious and adverse experiences created by the director of the Safety Section of the OHSR, Dr. Suzanne Gebhart. With support from the Pediatrics Navigator, 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. Given the diversity of pediatric patients in Atlanta, new estimates of functional health literacy through TOPHLA, the RSS works to evaluate parental consent for child participation and establishing functional literacy requirements for an informed assent process will be determined.
Statistical Approaches
Through the Biostatistics, Epidemiology, and Research Design within the ACTSI and current biostatistical support through CHOA, CTRPP statistics is led by multiple PhD level faculty statisticians with experience in Pediatric and special subjects studies.
Study management
Close integration and communication among the Principal Investigator, Lead Statistician, Data Manager/ Clinical Data Specialists and Navigator (Core team) assures successful trial methodology and implementation. This CTRPP "core" team is led by a Pediatric Navigator who is available to support the Pediatric Investigators in all aspects of protocol development and implementation. Through work with the OHSR and the Children's Research Oversight Committee (CROC) of CHOA, the Navigator is responsible for maintaining study timelines, balancing the study budget, and ensuring that the team works together effectively.
Processing laboratory and biobanking services
The Tranlational Technology Resources Program and the CIN Program 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, 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