U01AI178756

PPDS Application for the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01 Clinical Trial Not Allowed) - Project Summary/Abstract

To support DAIT's efforts to increase understanding of the causes and mechanisms that lead to the development of immunologic diseases and to expand knowledge that can be applied to improving techniques of diagnosis, treatment, and prevention, the T-SCCC will provide experienced staff, standardized procedures, optimal facilities, and integrated systems to transition-in and support statistical and clinical coordinating center deliverables for NIAID/DAIT's clinical research programs, investigator-initiated clinical trials, and other NIAID-funded clinical programs in transplantation.

The T-SCCC will empower DAIT's transplantation researchers to address key scientific questions and share resultant data by efficiently managing program and study resources and facilitating communication and collaboration among stakeholders from initial study and protocol concepts through to peer-reviewed manuscripts.

The T-SCCC will:

1) Provide experienced scientists and statisticians to collaborate with clinical investigators and DAIT to develop innovative statistical design and analysis plans for concept and full study proposals; conduct interim and final statistical analyses of clinical and mechanistic study data that will be used to yield optimal results for scientific manuscripts and reports for publication and presentation;

2) Provide high-quality adverse event/serious adverse event reporting that supports data and safety monitoring boards, other safety committees/bodies, and regulatory health authorities in ensuring study participant safety;

3) Provide dedicated, experienced protocol teams to help develop, review, and revise protocols and protocol-related documents and provide site training on protocol-related processes and procedures at startup and throughout studies to accommodate changes;

4) Establish and maintain a biospecimen tracking database and assemble and ship assay kits and/or bulk supplies that include biospecimen labeling packets (kitting) for mechanistic studies;

5) Help ensure complete, accurate clinical data collection and security by supporting data management plan development and study database design in collaboration with the CDSMC, investigators, SMTS, and DAIT;

6) Collaborate with the CDSMC, SMTS, and DAIT to monitor study participant safety, implement safety procedures, and adhere to safety oversight and reporting requirements;

7) Provide and maintain secure, user-permissioned, internet-based clinical study collaboration portals, to house clinical trial information and study-specific files and provide a mechanism to receive study data securely from the CDSMC for analysis, reporting, and sharing;

8) Develop and implement plans for collaborative project management, communications, and support of the complex web of stakeholders and processes involved in delivering the T-SCCC to ensure efficient, valid, and ethical study oversight, reporting, and conduct; and

9) Use well-developed standards and methods to build and implement a comprehensive, cross-functional quality assurance/quality control plan that standardizes quality processes across deliverables and facilitates assessments of T-SCCC performance.

PPD Development Lp

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]

Wilmington, North Carolina 284013331 United States

Single Zip Code

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

Amendment Since initial award the total obligations have increased 206% from $8,739,596 to $26,732,375.