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

项目摘要： 为保障国家安全，针对高后果的医学对策（MCM） 因此，必须开发高致病性病原体（HCP）来治疗和预防对全球健康的威胁。十五年 前，美国卫生与公众服务部食品和药物管理局 (FDA)发布了新药和生物制剂的最终规则; 当人体疗效研究不符合伦理或 可行（21 CFR第314和601部分，联邦公报，2002年5月31日）。动物法则（AR） 正如经常提到的，对于开发用于改善或预防严重或 由于暴露于致命或永久致残的有毒物质而导致的危及生命的状况 当人体功效研究不符合伦理且现场试验不可行时，FDA可以 在以下情况下，根据充分且受控良好的动物有效性研究授予上市许可 这些研究的结果表明，该药物有合理的可能产生临床效益 在人类身上。由于HCP的高传染性，这些研究通常在 高或最大生物防护（BSL-3/4）。确保数据准确可靠的物流 从这些环境中收集是具有挑战性的。随后对这些产品进行评估 在公共紧急状态下进行临床试验数据来自非临床AR研究 HCP的临床研究由FDA和全球监管机构审查， 因此，数据的质量和完整性至关重要。 2012年，FDA和德克萨斯大学加尔维斯顿医学分支（UTMB）合作 设计和实施一项教育计划，对赞助商、科学家、 兽医、医生、护士、质量保证人员、监管人员、审查人员和政策- 制造商，使监管研究的支持产品通过FDA的AR批准的行为。 这些研究需要符合FDA药物非临床研究质量管理规范（21 CFR）的规定 第58部分），以确保数据质量和完整性。结果是 从2013年起，为269名注册参与者提供了年度培训的强大教育计划- 2017. FDA和UTMB计划扩大教育计划课程， 解决HCP临床试验的进行，并扩大在线课程的目录， 远程教育在远程研究中心进行HCP临床试验的个人。获得的知识 将解决进展的障碍，并增加参与各方之间的沟通， 进行、决策、资助、审查和检查必要的研究， 促进MCMs的发展和保护人类健康。

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.