HHS establishes new clinical studies network

The Department of Health and Human Services recently announced that it established a network of five clinical research organizations to design and conduct clinical trials to develop medical countermeasures.

Countermeasures are vaccines, drugs and diagnostic tests meant to help protect against pandemic influenza, bioterrorism and other public health emergencies. The network will also be able to supplement the capabilities of the National Institutes of Health by conducting clinical studies during public health emergencies like pandemics.

The new network will provide a full range of services for planning, performing, monitoring and interpreting clinical studies. The U.S. Food and Drug Administration requires clinical studies to approve a product for human use, evaluate the potency of products in U.S. government stockpiles or compare the properties of multiple products.

"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," Robin Robinson, the director of the Biomedical Advanced Research and Development Authority.

BARDA will manage the clinical studies network, which includes the EMMES Corporation, PPD Development, LLC, Technical Resources International, Inc., Clinical Research Management, Inc., and Rho Federal Systems Division, Inc. The companies will receive a minimum guarantee of $400,000 over the first two years. Each contract can be extended for up to five years and be worth a maximum of $100 million.

BARDA provides a comprehensive integrated portfolio approach to the development, innovation, acquisition and manufacturing of MCMs.

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