Project: NIAID Division of Allergy, Immunology and Transplantation (DAIT): Statistical and Clinical Coordinating Center (SACCC)

Sponsor: NIH/National Institute of Allergy and Infectious Diseases (NIAID)

Prime: Rho

Project Status: Active

Project Start: May 2015

Diseases: Asthma and Allergic Diseases; Autoimmune Diseases; Transplantation of Cells, Tissues, and Solid Organs

Objective: The goal of DAIT is to explore how the immune system maintains health and, under abnormal conditions, also contributes to disorders. To achieve that goal, DAIT supports basic and clinical research to improve our understanding of the causes of immunologic diseases and to develop better diagnostic, treatment, and prevention strategies. Rho has supported DAIT’s clinical research programs since 1997 and is proud of the clinical standard manuscripts and novel interventions that have resulted from the DAIT-Rho long-term partnership.

As the DAIT SACCC, Rho is at the forefront of providing robust, full-service support that is critical to the design, development, execution, monitoring, and analysis of clinical research studies sponsored by DAIT. The DAIT SACCC is structured around the following 3 disease areas: Asthma and Allergic Diseases, Autoimmune Diseases, and Transplantation of Cells, Tissues, and Solid Organs. Rho supports 9 consortia that comprise the 3 disease area groups.

Asthma and Allergic Diseases Group (AADG):

• Inner-City Asthma Consortium (ICAC)
• Atopic Dermatitis Research Network (ADRN)
• Consortium of Food Allergy Research (CoFAR)
• Immune Tolerance Network (ITN)

Autoimmune Diseases Group (ADG):

• Autoimmunity Centers of Excellence (ACE)
• Hematopoietic Stem Cell Therapy Consortium (HSCTC)
• Immune Tolerance Network (ITN)

Transplantation Group (TG):

• Clinical Trials in Organ Transplantation Consortium (CTOT)
• Clinical Trials in Organ Transplantation in Children Consortium (CTOT-C)
• Genomics of Transplantation Cooperative Research Program (GTCRP)
• Immune Tolerance Network (ITN)

The 3 disease areas provide services in 3 functional areas: statistical design and analysis, protocol development, and study initiation and management. The disease area groups are supported by the following 5 centralized groups that provide support across all DAIT studies:

• Clinical Site Monitoring Group
• Data Management and Reporting Group
• Safety Oversight and Reporting Group
• Ancillary Services Group
• Bioinformatics Group

The scope of clinical research supported by the SACCC includes (i) all phases of clinical trials to evaluate the safety and efficacy of investigational products and innovative approaches for disease treatment and prevention; (ii) studies of genetics and underlying mechanisms of diseases and conditions, as integral components of clinical trials; (iii) observational studies (e.g., longitudinal birth cohort studies, natural history studies); and (iv) surrogate/biomarker studies.

Project Information: The DAIT SACCC award consolidated 6 major coordinating center awards into one 7-year (2015-2022), $168 million project (approximately $24 million per year). Prior to this award, Rho was the coordinating center for 5 of these 6 awards, and we had successfully recompeted several of these DAIT projects through multiple cycles. In addition, Rho successfully transitioned several of these projects from previous incumbents, including the ADCT, CTOT, and ITN coordinating centers.

The DAIT SACCC currently supports about 100 studies across 400+ clinical sites. To achieve this level of support, Rho deploys approximately 90 FTEs per year. A major accomplishment for Rho was the comprehensive standardization of processes and tools from 6 disparate coordinating centers into the single DAIT SACCC. Since standardization, Rho has continuously found ways to increase efficiency and streamline processes across projects and is a model to be replicated across other federal awards.

The DAIT SACCC supports clinical research that makes a real impact on the lives of both children and adults. Learn more about this impact through our featured DAIT SACCC studies:

• AADG/ITN: Promoting Tolerance to Peanut in High-Risk Children (LEAP); Persistence of Oral Tolerance to Peanut (LEAP-On)
• ADG/ITN: High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS)
• TG/CTOT-C: Alloantibodies in Pediatric Heart Transplantation (CTOT-C-04)

Services:

• Biostatistics and Statistical Programming*
• Bioinformatics
• Protocol Design/Development
• Study Initiation and Management
• Clinical Operations and Monitoring
• Clinical Data Management*
• Ancillary Services
• Product Safety and Pharmacovigilance Services*
• Clinical Project Management
• Study Document Management
• Study Website Content Development and Maintenance

* Indicate services provided to Immune Tolerance Network (ITN).