(Released 12 September 2017) Fort Belvoir, VA – When an outbreak as virulent and fast-moving as Ebola strikes, having resources to respond immediately can be the difference between life and death for both warfighters and civilians. To rapidly develop new treatments and medical countermeasures needed, the ability to conduct clinical research in a disease outbreak setting has significant advantages. The Defense Threat Reduction Agency’s Chemical and Biological Technologies Department recently participated in the Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC) Capability Exercise (CAPEX) to better prepare for the next outbreak.
Conducted in Fort Portal, Uganda, the CAPEX focused on JMEDICC hub site capabilities to screen patients, provide treatment and clinical care, and collect data to meet the rigor of the U.S. Food and Drug Administration (FDA) approval process for potential therapeutics.
Most development of Ebola medical countermeasures and treatment protocols is done by animal testing, as human testing in the absence of an outbreak would be unethical. However, animal model data is not always predictive, underscoring the importance of conducting clinical research when possible. During the 2014-2016 Ebola epidemic, the DoD was unable to acquire sufficient data to support FDA licensure of candidate drugs for the disease as protocols and procedures were not in place to conduct the research.
The Antiviral Program, within the Joint Program Executive Office, Medical Countermeasure Systems, Biodefense Therapeutics Program Office aims to establish a Department of Defense capability to rapidly execute human clinical research of experimental treatments in an emerging infectious disease outbreak setting.
The CAPEX demonstrated concepts and technical approaches that will be utilized in an isolation ward setting. These will be used to conduct filovirus therapeutic clinical trials to provide appropriate data to supplement a new FDA drug application submission. The CAPEX also demonstrated interoperability of the multiple processes needed for clinical trial execution and highlighted regulatory, diplomatic and logistical challenges. As part of the after action review, challenges and potential solutions were identified by CAPEX observers and will be incorporated into ongoing planning efforts to more fully develop the JMEDDIC hub site capabilities. In addition, they will inform plans to develop a mobile clinical research capability that would be deployed in the event of an outbreak.
The ability to conduct clinical trials in accordance with FDA requirements during an outbreak increases the probability of identifying efficacious medical countermeasures to treat emerging dangerous diseases. These efforts are vital to protect the warfighter and civilians, and further the ability to ensure more rapid drug development.
Lindsay Odell, Ph.D.