Combating Emerging Threats — Accelerating the Availability of Medical Therapies

A new paradigm for accelerating evaluation of investigational therapies during public health emergencies caused by emerging infectious diseases could permit therapies shown to be safe and effective to reach patients as soon as possible. Life-threatening emerging or reemerging infectious diseases increasingly inspire demands for access to novel, often untested therapies. Recent concern about transmission of the Middle East respiratory syndrome coronavirus (MERS-CoV) in Asia underscores the need to rapidly evaluate investigational therapies during outbreaks, identify those that actually benefit patients, and protect against those that cause harm. Although a traditional sequence of studies in animals followed by phased clinical trials works well for many therapeutics, that process may be too slow during public health emergencies. We propose establishing a new paradigm for accelerating evaluation of investigational therapies during public health emergencies so that therapies . . .