Project Summary
To protect global health and our nation’s security, medical countermeasures (MCMs) for high consequence
pathogens must be developed expeditiously. The planning and conduct of nonclinical studies and clinical
research trials for these MCMs are often performed in maximum containment laboratories or barrier nursing
environments. These environments present unique challenges and require complex solutions to assure the data
quality and integrity such that a regulatory decision can be made to advance the MCM in the regulatory approval
pathway. As such, an educational program to enhance data quality and integrity for regulated studies supporting
the advancement of medical countermeasures for high consequence pathogens was developed in 2013 by the
UTMB in collaboration with the FDA Office of Counterterrorism and Emerging Threats with consistent successful
outcomes as measured through course evaluations. Each course offered in the educational program is
credentialled for Continuing Education (CE) units for the corresponding target audience, to include physicians,
nurses, veterinarians, and quality assurance professionals.
The proposed research is a continuation of the robust, collaborative educational program using problem-based
learning techniques designed to bring the scientific, medical, regulatory community together to educate each
other on the challenges related to these issues and to identify solutions that are acceptable. The overall program
consists of a course to address nonclinical studies conducted under the FDA Animal Rule and clinical research
trials. Online companion courses in Good Laboratory Practice and Good Clinical Practice are included in the
educational program curriculum. In Aim 1 we will conduct a systematic educational program review and form a
DEI Advisory Panel. In Aim 2 we will continuously modify and update delivery of the Nonclinical Course
“Achieving Data Quality and Integrity in Maximum Containment Laboratories.” In Aim 3 we will continuously
modify and update delivery of the Clinical Course “Achieving Data Quality and Integrity in Clinical Trials Involving
High Consequence Pathogens.” Aim 4 addresses course credentialing, program sustainability, expansion into
One Health principles, and resource sharing.
The overall goal of this unique educational program is to provide a learning environment that promotes
collaboration of ideas, provides tools for clinical study conduct, enhances mutual understanding of clinical,
scientific, and regulatory complexities, and promotes the data quality and integrity derived from these regulated
studies. The outcome will be a better prepared, cohesive community of clinical, scientific, and regulatory experts
mutually engaged in, and committed to, the research, development, and regulatory evaluation and approval of
medical countermeasures for high consequence pathogens.