HHS: March 11, 2014
Network can prepare, conduct clinical studies for drugs to protect health in emergencies
HHS today established a network of five clinical research organizations that will design and conduct clinical studies needed to develop medical countermeasures – drugs, vaccines, and diagnostic tests that help protect health against bioterrorism, pandemic influenza, and other public health emergencies.
The new clinical studies network will provide a full range of services required to plan, perform, monitor, and interpret clinical studies. The services include performing clinical studies that are required by the U.S. Food and Drug Administration for the approval of a product for human use, comparing the properties of multiple products, or evaluating the potency of products stored in U.S. government stockpiles.
If needed, the network will also be able to supplement National Institute of Health capabilities by conducting clinical studies during public health emergencies such as a pandemic. This capability will enhance the nation’s science preparedness by ensuring that clinical studies that address critical research questions for emergency response and recovery can be performed in a timely manner.
“Recent disasters, such as Hurricane Sandy, the Deepwater Horizon oil spill, the 2009-H1N1 pandemic, underscored the importance of developing a capability to perform rigorous scientific studies in real time, potentially to shape the response to an unfolding crisis and to support recovery,” explained Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA). BARDA is part of the HHS Office of the Assistant Secretary for Preparedness and Response and will manage the clinical studies network. Read More