An Educational Program to Enhance Data Quality and Integrity for Regulated Studies Supporting the Advancement of Medical Countermeasures for High Consequence Pathogens - 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.
