1. The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research
- Author
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Prossy Naluyima, Willy Kayondo, Chi Ritchie, Joseph Wandege, Sharon Kagabane, Lydia Tumubeere, Brenda Kusiima, Daniel Kibombo, Sharon Atukunda, Christine Nanteza, Harriet Nabirye, Francis Bunjo Mugabi, Sarah Namuyanja, Christopher Hatcher, Hypaitia Rauch, Moses Mukembo, Patrick Musinguzi, JMEDICC Consortium, Nathan Sanders, Elizabeth Turesson, Christian Cando, Richard Walwema, Derrick Mimbe, Janice Hepburn, Danielle Clark, Mohammed Lamorde, Hannah Kibuuka, Saima Zaman, Anthony P Cardile, and Karen A Martins
- Subjects
0301 basic medicine ,RNA viruses ,INVESTIGATIONAL VACCINES ,Research Facilities ,RC955-962 ,Disease ,medicine.disease_cause ,Pathology and Laboratory Medicine ,Disease Outbreaks ,Geographical Locations ,0302 clinical medicine ,Arctic medicine. Tropical medicine ,Medicine and Health Sciences ,Uganda ,Data Management ,Clinical Trials as Topic ,Hematology ,Clinical Laboratory Services ,Clinical Laboratory Sciences ,Viewpoints ,Clinical Laboratories ,Infectious Diseases ,Medical Microbiology ,Filoviruses ,Viral Pathogens ,Viruses ,Medical emergency ,Public aspects of medicine ,RA1-1270 ,Pathogens ,Research Laboratories ,Ebola Virus ,Computer and Information Sciences ,Drug Research and Development ,030231 tropical medicine ,Research and Analysis Methods ,Microbiology ,03 medical and health sciences ,Diagnostic Medicine ,medicine ,Disease Transmission, Infectious ,Humans ,Clinical Trials ,Microbial Pathogens ,Pharmacology ,Ebola virus ,Biology and life sciences ,business.industry ,Hemorrhagic Fever Viruses ,Public Health, Environmental and Occupational Health ,Organisms ,Outbreak ,medicine.disease ,United States ,Clinical trial ,Intervention (law) ,030104 developmental biology ,Clinical research ,New product development ,People and Places ,Africa ,Communicable Disease Control ,Business ,Clinical Medicine ,Government Laboratories - Abstract
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., Author summary Conducting clinical research during high-consequence pathogen outbreaks engenders complications not experienced in standard clinical research. In addition to regulatory expertise, international stakeholder engagement—including community outreach into research-naive local communities—is required, as are the technical clinical, laboratory, and infection prevention and control expertise that enables the safe and effective execution of the study in hazardous circumstances. Since the 2013–2016 Ebola virus outbreak in West Africa, researchers and public health officials alike have recognized the need to discuss these challenges. The Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC) is a unique project tasked with pre-positioning a team of highly skilled clinical researchers to execute therapeutics clinical trials during a filovirus outbreak. The project has been operating in Fort Portal, Uganda, since 2016 and is preparing to conduct clinical research if the current Ebola outbreak in the Democratic Republic of Congo spreads to Uganda. The capability is not necessarily specific for filoviruses, however, but could be utilized for high-containment clinical trial work for other high-consequence pathogens.
- Published
- 2019