The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research.

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

Instrument selection.

Instrument selection.</p

Map of Uganda and the bordering area of the DRC.

Fort Portal, the JMEDICC hub site in Uganda, is located in the western part of Uganda near the border with the DRC and is circled in red; Beni and Butembo in DRC, sites of the 2018–present DRC Ebola virus outbreak, also shown and circled in red. Map taken from the CIA website the Uganda Physiography map https://www.cia.gov/library/publications/resources/cia-maps-publications/Uganda.html. CIA, Central Intelligence Agency; DRC, Democratic Republic of Congo; JMEDICC, Joint Mobile Emerging Disease Intervention Clinical Capability.</p

Core capability considerations.

Core capability considerations.</p

The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research - Fig 2

JMEDICC execution schematic highlighting (A) JMEDICC approach of increasing complexity as competency is established and (B) the multifaceted nature of the project preparedness and response. JMEDICC, Joint Mobile Emerging Disease Clinical Capability.</p