The U.S. Department of Health and Human Services 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.
In an emergency, the BARDA clinical studies network may use local institutional review boards or the national Public Health Emergency Research Review Board, a central institutional review board administered by the National Institutes of Health to review multi-site research studies on health problems arising in the context of a public health emergency. Both types of boards assure that appropriate steps are taken to protect the rights and welfare of people participating as subjects in the research.
The clinical studies network will support BARDA-funded medical countermeasure developers and conduct clinical studies on behalf of BARDA. The activities of BARDA’s clinical studies network will be coordinated with those of HHS interagency and industry partners, including the National Institute of Allergy and Infectious Diseases (NIAID).
ASPR awarded contracts to five U.S. companies that will make up the network’s clinical studies. Today’s contracts are with EMMES Corporation of Rockville, Md.; PPD Development LLC of Wilmington, N.C.; Technical Resources International Inc. of Bethesda, Md.; Clinical Research Management, Inc. of Hinckley, Ohio, and Rho Federal Systems Division Inc. of Chapel Hill, N.C.
Each contract includes a minimum guarantee of $400,000 over the initial two years for access to the clinical research organization’s services. Each contract can be extended for up to a total of five years and a maximum of a $100 million. Clinical studies will be performed through the network based on proposals provided by the network members in response to specific BARDA requests.
The new clinical studies network expands the core service assistance programs through BARDA to aid medical countermeasure development. In addition to the clinical studies network, BARDA oversees a nonclinical development network, Centers of Innovation in Advanced Development and Manufacturing (CIADMs), and a fill finish manufacturing network.
The nonclinical development network supports preclinical testing of medical countermeasures while the CIADMs provide an array of manufacturing services and influenza vaccine surge manufacturing capacity. The fill finish manufacturing network covers the final steps in the vaccine manufacturing process and supplements the filling capacity of current influenza vaccine manufacturers.
BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. To learn more about HHS, visit www.hhs.gov