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

一项旨在提高监管研究数据质量和完整性的教育计划，支持针对高后果病原体的医学对策的进展

• 批准号: 10711079
• 负责人: Trevor Brasel
• 金额: $ 40万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-20 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10711079
• 关键词: Educational; Program; Enhance; Data; Quality

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.

项目概要 为了保护全球健康和国家安全，采取高后果的医疗对策（MCM） 必须迅速开发病原体。非临床研究和临床研究的规划和实施 这些 MCM 的研究试验通常在最大密闭实验室或屏障护理中进行 环境。这些环境提出了独特的挑战，需要复杂的解决方案来确保数据 质量和完整性，以便可以做出监管决策以推进 MCM 获得监管批准 途径。因此，一项旨在提高受监管研究的数据质量和完整性的教育计划支持 2013 年，世界卫生组织制定了针对严重后果病原体的医疗对策进展 UTMB 与 FDA 反恐和新兴威胁办公室合作，取得了持续成功 通过课程评估衡量的结果。教育计划中提供的每门课程都是 获得相应目标受众（包括医生）的继续教育（CE）单元认证， 护士、兽医和质量保证专业人员。 拟议的研究是使用基于问题的强大协作教育计划的延续 旨在将科学、医学和监管界聚集在一起的学习技术，以教育每个人 讨论与这些问题相关的挑战，并确定可接受的解决方案。总体方案 包括一门课程，涉及根据 FDA 动物规则进行的非临床研究和临床研究 试验。良好实验室规范和良好临床实践的在线配套课程包含在 教育计划课程。在目标 1 中，我们将进行系统的教育计划审查，并形成一个 DEI 顾问小组。在目标 2 中，我们将不断修改和更新非临床课程的交付 “在最大程度的遏制实验室中实现数据质量和完整性。”在目标 3 中，我们将不断 修改和更新临床课程“在涉及以下内容的临床试验中实现数据质量和完整性”的交付 高后果病原体。”目标 4 涉及课程认证、项目可持续性、扩展到 “同一个健康”原则和资源共享。 这个独特的教育计划的总体目标是提供一个学习环境，促进 思想协作，为临床研究行为提供工具，增强临床相互理解， 科学和监管的复杂性，并提高从这些监管中获得的数据质量和完整性 研究。结果将是一个由临床、科学和监管专家组成的准备更充分、更有凝聚力的社区 共同参与并致力于研究、开发以及监管评估和批准 针对严重后果病原体的医疗对策。