A two-day workshop was recently held in Washington, D.C. that addressed methods of building up the U.S. ability to monitor and analyze its medical countermeasures for use in public health emergencies.
Hosted by the National Academies of Sciences, Engineering, and Medicine, the workshop focused on a number of different areas, including chemical, biological, radiological, nuclear and infectious disease-based catastrophes. The focus was not, however, on the spread or damage of these dangers. It was on limiting that damage through drugs, vaccines, and devices collectively known as medical countermeasures (MCMs).
Entitled Going Beyond the Last Mile, it touted the push for more than mere response to such disasters and treating them, but rather, to build, maintain and administer a national capability to monitor and assess the use of MCMs both during and ahead of such disasters.
“Although an MCM may be developed and potentially approved for an intended indication…the specific situation in which it will be used remains unknown until the time of a PHE,” the workshop proceedings noted. “The uncertainty makes it difficult to prospectively craft protocol designs and determine elements of clinical research that will be adaptable to a broad range of situations.”
A primary goal was to promote having predefined protocols in advance of such public health emergencies, but also encouraged applying data analysis, depending on a safety monitoring board, considering the availability of MCMs and analyzing the impact of a disaster’s scale on any potential protocol design to determine the appropriate response. Workshop organizers also noted the importance of having control groups during MCM clinical studies for purposes of data interpretation as well as the importance of data collection during these events, as use of these items beforehand could be restricted to animals.