HHS through the Office of the Assistant Secretary for Preparedness and Response (ASPR) has designated five clinical research organizations to design and conduct clinical studies on drugs, vaccines, and diagnostic tests to help protect against bioterrorism, pandemic influenza, and other public health emergencies.
NIH’s Biomedical Advanced Research and Development Authority (BARDA) which is within ASPR will manage the clinical studies network. Clinical studies will be performed based on proposals provided by network members in response to specific BARDA requests.
The new clinical studies network will provide a full range of services needed to plan, perform, monitor, and interpret clinical studies that are required by FDA to approve a product for human use, compare properties of multiple products, and evaluate the potency of products stored in U.S government stockpiles.
If needed, the network will also supplement NIH capabilities by conducting clinical studies during public health emergencies as in the case of a pandemic. This capability will ensure that clinical studies address critical research questions for emergency response so that recovery can be performed in a timely manner.
The five U.S. companies make up the network’s clinical studies are EMMES Corporation of Rockville, MD, PPD Development LLC of Wilmington, North Carolina, Technical Resources International Inc. of Bethesda, Maryland, Clinical Research Management Inc. of Hinckley Ohio, and Rho Federal Systems Division Inc. of Chapel Hill, North Carolina.
Each contract includes a minimum guarantee of $400,000 over the initial two years to use to access services available at clinical research organizations. Each contract can be extended for up to a total of five years and for a maximum of $100 million. Clinical studies will be performed through the network based on the proposals provided by the network members in response to specific BARDA requests.