What do the Boston Marathon bombing and the Ebola epidemic have in common?
The lessons learned in responding to the attack and the viral epidemic will help advance medical countermeasures (MCMs) and future emergency responses.
Key to learning those lessons is acquiring the necessary data, J. Perren Cobb, medical director of the surgical intensive care unit at Massachusetts General Hospital and an assistant professor at Harvard Medical School, said at the FDA Science Forum Wednesday. But that's easier said than done, especially when it comes to assessing the outcomes of investigational therapies and diagnostics.
The biggest data challenge is determining whether and how the therapies worked, Cobb said. Another hurdle is getting institutional review boards (IRBs) to approve the necessary research while an emergency or disaster is unfolding.
Addressing those difficulties, the U.S. Critical Illness and Injury Trials Group (