HHS has established a network of 5 clinical research organizations to design and conduct clinical studies about medical countermeasures—drugs, vaccines, and diagnostic tests—to protect against bioterrorism, pandemics, and other public health emergencies. “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,” said Robin Robinson, PhD, director of the Biomedical Advanced Research and Development Authority (BARDA) in a HHS press release.
Part of the HHS Office of the Assistant Secretary for Preparedness and Response, BARDA will manage the network, coordinating with HHS interagency and industry partners, such as the National Institute of Allergy and Infectious Diseases. The new network will provide a full range of services, including planning, performing, monitoring, and interpreting clinical studies.
BARDA takes a “comprehensive integrated portfolio” approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and nonpharmaceutical products for public health emergency threats, HHS said. For instance, the clinical studies network may use local institutional review boards or the national Public Health Emergency Research Review Board to review multisite studies on health problems arising during a public health emergency. (Both types of boards ensure that appropriate steps are taken to protect the rights and welfare of people participating as subjects.)
Clinical studies will be performed through the network based on proposals provided by network members in response to specific BARDA requests. Five companies have been awarded contracts: EMMES Corporation in Rockville and Technical Resources International, Inc., in Bethesda, both in Maryland; PPD Development, LLC, in Wilmington and Rho Federal Systems Division, Inc., in Chapel Hill, both in North Carolina; and Clinical Research Management, Inc., in Hinckley, Ohio. The contracts include a minimum guarantee of $400,000 over the initial 2 years for access to the clinical research organization’s services. Each contract can be extended for up to 5 years and for a maximum of $100 million.