预先部署的突发疫情研究：乌干达联合医学新发传染病干预临床能力经验。
Pre-positioned Outbreak Research: The Joint Medical Emerging Diseases Intervention Clinical Capability Experience in Uganda.
机构信息
Karen A. Martins, PhD, is Research Health Science Program Manager, Medical Division; Chi Ritchie, MT, M(ASCP), is a Microbiologist; and Sina Bavari, PhD, is Science Director; all at the US Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD. Rodgers R. Ayebare, MB ChB, CIC, is Site Coordinator; and Peter Waitt, MD, is Clinical Lead, Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC), Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda. Nahid Bhadelia, MD, MA, is Associate Professor and Medical Director, Special Pathogens Unit, Section of Infectious Diseases, Boston University School of Medicine, Boston, MA. Francis Kiweewa, MD, is Head of Research and Scientific Affairs, Makerere University Walter Reed Project, and Strengthening Institutional Capacity for Research Administration (SICRA), Kampala, Uganda. Derrick Mimbe, MSC, and Stephen Okello, MD, are Program Managers, JMEDICC; Prossy Naluyima, PhD, is Laboratory Director; and Hannah Kibuuka, MD, is Executive Director, all in the Makerere University Walter Reed Project, Kampala, Uganda. David M. Brett-Major, MD, MPH, is a Professor, College of Public Health, and James V. Lawler, MD, MPH, is Executive Director, International Programs and Innovation, Global Center for Health Security and Division of Infectious Diseases; both at the University of Nebraska Medical Center, Omaha, NE. Monica Millard, MPH, is Country Program Director, US Army Medical Research Directorate-Africa/Uganda (MRD-A/U), Walter Reed Army Institute of Research (WRAIR), Kampala, Uganda. Richard Walwema is a Laboratorian, and Mohammed Lamorde, PhD, is Head of Global Health Security, Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda. Anthony P. Cardile, DO, is at the Richard Barquist US Army Health Clinic, Ft. Detrick, MD. Antonia Kwiecien and Helen Badu are International Program Managers-Uganda, and Danielle V. Clark, PhD, is Director; all at Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO), Henry M. Jackson Foundation, Bethesda, MD. Benjamin J. Espinosa, PhD, is Deputy Director, Biological Defense Research Directorate, Naval Medical Research Center, Frederick, MD. Charmagne Beckett, MD MPH, is with the Infectious Diseases Directorate, Naval Medical Research Center, Silver Spring, MD. Saima Zaman, MPH, is International Project Manager, Biological Threat Reduction Program, Defense Threat Reduction Agency, Fort Belvoir, VA. George Christopher, MD, is Joint Project Manager, Chemical, Biological, Radiological, and Nuclear Medical, Joint Program Executive Office for CBRN Defense, US Department of Defense, Fort Detrick, MD.
出版信息
Health Secur. 2020 Mar/Apr;18(2):114-124. doi: 10.1089/hs.2019.0112.
The West Africa Ebola virus disease outbreak of 2014-2016 demonstrated that responses to viral hemorrhagic fever epidemics must go beyond emergency stopgap measures and should incorporate high-quality medical care and clinical research. Optimal patient management is essential to improving outcomes, and it must be implemented regardless of geographical location or patient socioeconomic status. Coupling clinical research with improved care has a significant added benefit: Improved data quality and management can guide the development of more effective supportive care algorithms and can support regulatory approvals of investigational medical countermeasures (MCMs), which can alter the cycle of emergency response to reemerging pathogens. However, executing clinical research during outbreaks of high-consequence pathogens is complicated and comes with ethical and research regulatory challenges. Aggressive care and excellent quality control must be balanced by the requirements of an appropriate infection prevention and control posture for healthcare workers and by overcoming the resource limitations inherent in many outbreak settings. The Joint Mobile Emerging Disease Intervention Clinical Capability was established in 2015 to develop a high-quality clinical trial capability in Uganda to support rigorous evaluation of MCMs targeting high-consequence pathogens like Ebola virus. This capability assembles clinicians, laboratorians, clinical researchers, logisticians, and regulatory professionals trained in infection prevention and control and in good clinical and good clinical laboratory practices. The resulting team is prepared to provide high-quality medical care and clinical research during high-consequence outbreaks.
2014-2016 年西非埃博拉病毒病疫情表明，对病毒性出血热疫情的应对措施必须超越应急权宜之计，应纳入高质量的医疗护理和临床研究。最佳的患者管理对于改善预后至关重要，无论地理位置或患者社会经济地位如何，都必须实施这一措施。将临床研究与改善护理相结合具有显著的附加效益：提高数据质量和管理水平有助于制定更有效的支持性护理算法，并支持针对研究性医疗对策（MCM）的监管批准，从而改变对重新出现病原体的应急反应周期。然而，在高后果病原体疫情期间开展临床研究较为复杂，且存在伦理和研究监管方面的挑战。积极的护理和卓越的质量控制必须与医护人员适当的感染预防和控制姿态的要求相平衡，并克服许多疫情环境中固有的资源限制。联合机动新发传染病干预临床能力于 2015 年成立，旨在乌干达建立高质量的临床试验能力，以支持对埃博拉病毒等高后果病原体的 MCM 进行严格评估。这一能力汇聚了接受过感染预防和控制以及良好临床和良好临床实验室实践培训的临床医生、实验室人员、临床研究人员、后勤人员和监管专业人员。由此组建的团队已准备好在高后果疫情期间提供高质量的医疗护理和临床研究。
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