U01AI178772

RHOFED AA-SCCC - Project Summary/Abstract

The cooperative agreement funded by this Funding Opportunity Announcement establishes an Asthma and Allergy Statistical and Clinical Coordinating Center (AA-SCCC), which will further NIAID’s mission to support clinical research aimed at developing new or improved strategies to treat or prevent allergic diseases and asthma.

The objective of the AA-SCCC is to provide excellent and efficient coordination of the following services: protocol development, study initiation and management, statistical design and analysis, and biological specimen repository management.

To accomplish these objectives, RHO aims to:

1. Provide staff experienced in research conducted by NIAID-supported research networks and to organize these staff in an administrative structure that manages resources efficiently, is responsive to the needs of the research networks and NIAID, and facilitates communication and collaboration.

2. Provide experienced scientists and statisticians who, in collaboration with clinical investigators and NIAID officials, design and analyze studies across the full scope of research.

3. Facilitate the development, review, and revision of research protocols and protocol-related documents through dedicated protocol teams.

4. Provide study initiation and study management functions that are required for the efficient, valid, and ethical conduct of studies.

5. Continuously monitor the accuracy and completeness of research data.

6. Help ensure patient safety by providing high-quality adverse event surveillance and data and safety monitoring board (DSMB) reports.

7. Provide for secure storage of biospecimens, along with their distribution for innovative mechanistic research.

8. Effectively collaborate with the other components of the NIAID Clinical Research Program, e.g. the NIAID Regulatory Management Center (RMC), the Clinical Data and Safety Management Center (CDSMC), the Clinical Site Monitoring Center (CSMC), and the Clinical Products Center (CPC).

Based on more than 25 years of experience coordinating all aspects of clinical research in asthma and allergic diseases, we will use our current technology infrastructure, combined with new and innovative techniques to streamline and automate processes; provide easy access to data for DAIT, clinical investigators, and other key research stakeholders; allow for flexibility of staffing and resource sharing; standardize processes and methodologies across research networks where practicable; and continue to provide the flexibility necessary to meet the changing demands of this dynamic research program.

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]

Durham, North Carolina 277132230 United States

Single Zip Code

Allergy and Asthma Statistical and Clinical Coordinating Center (AA-SCCC) (U01 Clinical Trial Not Allowed) (RFA-AI-22-054)

Amendment Since initial award the total obligations have increased 215% from $8,941,982 to $28,163,551.