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The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research.
PLOS Neglected Tropical Diseases ( IF 3.4 ) Pub Date : 2019-12-19 , DOI: 10.1371/journal.pntd.0007787 Prossy Naluyima 1 , Willy Kayondo 1 , Chi Ritchie 2 , Joseph Wandege 1 , Sharon Kagabane 1 , Lydia Tumubeere 1 , Brenda Kusiima 3 , Daniel Kibombo 3 , Sharon Atukunda 1 , Christine Nanteza 1 , Harriet Nabirye 1 , Francis Bunjo Mugabi 1 , Sarah Namuyanja 3 , Christopher Hatcher 2 , Hypaitia Rauch 2 , Moses Mukembo 4 , Patrick Musinguzi 4 , , Nathan Sanders 5 , Elizabeth Turesson 6 , Christian Cando 7 , Richard Walwema 3 , Derrick Mimbe 1 , Janice Hepburn 8 , Danielle Clark 8 , Mohammed Lamorde 3 , Hannah Kibuuka 1 , Saima Zaman 7 , Anthony P Cardile 2 , Karen A Martins 2
PLOS Neglected Tropical Diseases ( IF 3.4 ) Pub Date : 2019-12-19 , DOI: 10.1371/journal.pntd.0007787 Prossy Naluyima 1 , Willy Kayondo 1 , Chi Ritchie 2 , Joseph Wandege 1 , Sharon Kagabane 1 , Lydia Tumubeere 1 , Brenda Kusiima 3 , Daniel Kibombo 3 , Sharon Atukunda 1 , Christine Nanteza 1 , Harriet Nabirye 1 , Francis Bunjo Mugabi 1 , Sarah Namuyanja 3 , Christopher Hatcher 2 , Hypaitia Rauch 2 , Moses Mukembo 4 , Patrick Musinguzi 4 , , Nathan Sanders 5 , Elizabeth Turesson 6 , Christian Cando 7 , Richard Walwema 3 , Derrick Mimbe 1 , Janice Hepburn 8 , Danielle Clark 8 , Mohammed Lamorde 3 , Hannah Kibuuka 1 , Saima Zaman 7 , Anthony P Cardile 2 , Karen A Martins 2
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Following the 2013-2016 Ebola virus outbreak in West Africa, numerous groups advocated for the importance of executing clinical trials in outbreak settings. The difficulties associated with obtaining reliable data to support regulatory approval of investigational vaccines and therapeutics during that outbreak were a disappointment on a research and product development level, as well as on a humanitarian level. In response to lessons learned from the outbreak, the United States Department of Defense established a multi-institute project called the Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC). JMEDICC's primary objective is to establish the technical capability in western Uganda to execute clinical trials during outbreaks of high-consequence pathogens such as the Ebola virus. A critical component of clinical trial execution is the establishment of laboratory operations. Technical, logistical, and political challenges complicate laboratory operations, and these challenges have been mitigated by JMEDICC to enable readiness for laboratory outbreak response operations.
中文翻译：
联合移动新发疾病临床能力 (JMEDICC) 实验室方法：高后果病原体临床研究能力。
2013-2016 年西非埃博拉病毒爆发后，许多团体主张在疫情爆发地区进行临床试验的重要性。在那次疫情爆发期间，获得可靠数据以支持研究疫苗和治疗方法的监管批准存在困难，这在研究和产品开发水平以及人道主义水平上令人失望。为了吸取此次疫情的教训，美国国防部建立了一个名为联合移动新发疾病干预临床能力（JMEDICC）的多机构项目。 JMEDICC 的主要目标是在乌干达西部建立技术能力，以便在埃博拉病毒等严重病原体爆发期间执行临床试验。临床试验执行的一个关键组成部分是实验室操作的建立。技术、后勤和政治挑战使实验室操作变得复杂，JMEDICC 已缓解这些挑战，以便为实验室疫情应对操作做好准备。
更新日期：2019-12-20
中文翻译：
联合移动新发疾病临床能力 (JMEDICC) 实验室方法：高后果病原体临床研究能力。
2013-2016 年西非埃博拉病毒爆发后，许多团体主张在疫情爆发地区进行临床试验的重要性。在那次疫情爆发期间，获得可靠数据以支持研究疫苗和治疗方法的监管批准存在困难，这在研究和产品开发水平以及人道主义水平上令人失望。为了吸取此次疫情的教训，美国国防部建立了一个名为联合移动新发疾病干预临床能力（JMEDICC）的多机构项目。 JMEDICC 的主要目标是在乌干达西部建立技术能力，以便在埃博拉病毒等严重病原体爆发期间执行临床试验。临床试验执行的一个关键组成部分是实验室操作的建立。技术、后勤和政治挑战使实验室操作变得复杂，JMEDICC 已缓解这些挑战，以便为实验室疫情应对操作做好准备。
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