Academic Development of a Training Program for GLP in ABSL 3/4

项目总结： 为了保护国家安全，医学对策(MCM)后果严重 必须开发病原体(HCP)来治疗和预防对全球健康的威胁。十五年 之前，美国卫生与公众服务部食品和药物管理局 (FDA)发布了新药和生物药物产品的最终规则；需要证据 在人类功效研究不符合伦理或不符合道德的情况下证明新药的有效性 可行性(21 CFR Parts 314和601，《联邦公报》，2002年5月31日)。动物法则(AR)， 正如经常引用的那样，对于为改善或预防严重的或 因接触致命性或永久性致残的有毒物质而导致的危及生命的情况 物质，当人体功效研究不符合伦理且现场试验不可行时，FDA可 在以下情况下，根据充分和良好控制的动物功效研究批准上市 这些研究的结果表明，这种药物合理地有可能产生临床益处。 在人类身上。由于HCP的高度传染性，这些研究通常在 高或最大生物遏制(BSL-3/4)。确保数据准确可靠的后勤保障 从这些环境中收集数据是具有挑战性的。随后对这些产品进行评估 通过在公共紧急情况下的临床试验。来自非临床AR研究的数据 FDA和全球权威机构对HCP的临床研究进行了审查，以得出 结论：因此，数据质量和完整性势在必行。 2012年，FDA和德克萨斯大学加尔维斯顿分校(UTMB)合作 设计和实施一项教育计划，以交叉教育赞助商、科学家、 兽医、医生、护士、质量保证人员、监管机构、审查员和政策- 制造商能够通过FDA的AR进行支持产品批准的受监管研究。 这些研究要求遵守FDA《良好实验室操作规程》(21 CFR 第58部分)，以确保数据质量和完整性。结果是一个 稳健的教育计划，从2013年开始为269名注册参与者提供年度培训- 2017年。FDA和UTMB计划扩大教育计划课程，将一门课程包括在内 解决进行HCP临床试验的问题，并扩大在线课程目录 对在偏远地点进行HCP临床试验的个人进行远程教育。获得的知识 将消除取得进展的障碍并加强参与的各方之间的沟通 进行、制定政策、资助、审查和检查必要的研究 发展中医药与保护人类健康。

Project Summary: To protect our nation's security, medical countermeasures (MCMs) for high consequence pathogens (HCPs) must be developed to treat and prevent threats to global health. Fifteen years ago, the United States Department of Health and Human Services Food and Drug Administration (FDA) published the final rule for New Drug and Biological Drug Products; Evidence needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible (21 CFR Parts 314 and 601, Federal Register, May 31, 2002). The Animal Rule (AR), as often referenced, states that for drugs/biologics developed to ameliorate or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic substances, when human efficacy studies are not ethical and field trials are not feasible, FDA may grant marketing approval based on adequate and well-controlled animal efficacy studies when the results of those studies establish that the drug is reasonably likely to produce clinical benefit in humans. Because of the highly infectious nature of HCPs, these studies are often performed in high or maximum biocontainment (BSL-3/4). The logistics of assuring accurate and reliable data collected from these environments is challenging. These products are subsequently evaluated through clinical trials during a public emergency. Data derived from the nonclinical AR studies and the clinical studies for HCPs are reviewed by FDA and global authorities to draw a regulatory conclusion; therefore, data quality and integrity are imperative. In 2012, the FDA and the University of Texas Medical Branch at Galveston (UTMB) collaborated to design and implement an education program to cross educate sponsors, scientists, veterinarians, physicians, nurses, quality assurance personnel, regulators, reviewers, and policy- makers to enable the conduct of regulated studies supporting product approval via the FDA's AR. These studies require compliance with the FDA Good Laboratory Practice regulations (21 CFR Part 58) to the extent practicable in order to assure data quality and integrity. The result was a robust education program that delivered annual training to 269 registered attendees from 2013- 2017. The FDA and UTMB plan to expand the education program curriculum to include a course addressing the conduct of HCP clinical trials and also expand the catalog of on-line courses for distance education of individuals conducting HCP clinical trials at remote sites. Knowledge gained will address barriers to progress and increase communication between parties involved in the conduct, policy-making, funding, review, and inspections of studies necessary for the advancement of MCMs and protection of human health.