Clinical Studies Network to Help in Health Emergencies

In March, the U.S. Department of Health and Human Services established a network of five clinical research organizations aimed to design and conduct clinical studies required to develop medical countermeasures, including vaccines, drugs and diagnostic tests, that can help protect Americans against bioterrorism, pandemic influenza and other widespread health emergencies. The Biomedical Advanced Research and Development Authority (BARDA) clinical studies network includes EMMES Corp. 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. Contracts with each of these companies include a minimum guarantee of $400,000 over the first two years for access to the clinical research organizations’ resources. And, the contracts can be extended for up to a total of five years and a maximum of $100 million.

The BARDA clinical studies network will offer a complete gamut of services needed to plan, perform, monitor and interpret clinical studies. The services will also 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 various products, or measuring the effectiveness of products kept in U.S. government reserves. In addition, the network will be able to enhance National Institutes of Health capabilities by conducting clinical studies in the event of a public health emergency. In the event of an emergency, the network will have the ability to use local institutional review boards or the national Public Health Emergency Research Review Board.