U01AI178768

RHOFED T-SCCC - Project Summary/Abstract

Through this funding opportunity announcement, NIAID is establishing a Transplantation Statistical and Clinical Coordinating Center (T-SCCC) to provide statistical design and analysis, study management, and biospecimen support services for transplant studies funded through NIAID-supported research networks, including ITN, CTOT, and CTOT-CA.

As the current NIAID Division of Allergy, Immunology and Transplantation Statistical and Clinical Coordinating Center (DAIT SACCC), providing statistical design and analysis, study management, and biospecimen support, as well as data management, safety surveillance support, and clinical monitoring services for transplant studies, RHO is uniquely well-suited to serve as the T-SCCC.

Our objective is to provide excellent service for all activities required per the T-SCCC RFA and to collaborate with NIAID leadership and staff and other NIAID-supported service centers to facilitate efficient provision of all clinical support services for all transplant studies across all the research consortia.

To accomplish this objective, RHO will:

1. Provide leadership and staff with experience in organ transplantation research and the administrative infrastructure needed to manage resources efficiently, to resolve technical and operational issues, and to facilitate effective interaction and collaboration within and between the T-SCCC, investigators, DAIT colleagues, other DAIT-supported service centers, consortia leadership, oversight boards, and regulatory agencies.

2. Provide advanced expertise in biostatistics for the efficient design and analysis of observational, interventional, and mechanistic studies in organ transplantation, including analysis of clinical and mechanistic data, preparation of statistical analysis plans in collaboration with investigators and NIAID personnel, and preparation of study reports, presentations, and manuscripts.

3. Provide scientific and operational leadership as well as technical and administrative support to enhance communication among study management team members, enable efficient development of protocols and protocol-related documents, expedite study initiation through skillful synchronization of initiation activities, manage oversight of study implementation at the sites, and aid in ensuring proper study conduct and collection of high-quality data.

4. Provide experienced staff to determine study needs for biospecimen collection, processing, and shipping; to design study- and visit-specific biospecimen kits as needed; to arrange for procurement of supplies either in bulk or via a web-based supply management system for ordering kits; and to train clinical site personnel on the use of the web-based supply management system.

5. Provide state-of-the-art web-based management systems for tracking the collection, handling, labeling, shipping, storage, disposal, and reporting of biological samples and for the reconciliation of data results corresponding to biological samples, and experienced staff to train clinical personnel on the collection and handling of samples and the use of the web-based systems.

RHO Federal Systems Division

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

North Carolina United States

State-Wide

Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01 Clinical Trial Not Allowed) (RFA-AI-22-057)

Amendment Since initial award the End Date has been extended from 04/30/24 to 04/30/25 and the total obligations have decreased from $1,494,050 to $1,493,430.