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.

Credit: CDC

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Citation: Naluyima P, Kayondo W, Ritchie C, Wandege J, Kagabane S, Tumubeere L, et al. (2019) The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research. PLoS Negl Trop Dis 13(12): e0007787. https://doi.org/10.1371/journal.pntd.0007787

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