FHI Chosen For Tropical Disease Research Support Center -- March 6, 2000

RESEARCH TRIANGLE PARK, NC -- The National Institutes of Health has selected Family Health International (FHI) to manage an international center to support research involving tropical and other infectious diseases. Historically, FHI has focused on reproductive health research, including reproductive tract infections and HIV/AIDS.

Under a five-year contract with the National Institute of Allergy and Infectious Diseases (NIAID), FHI will operate an international support center working with scientists in Africa and other tropical regions. The agreement is expected to bring $4 million to FHI over the five years.

The research itself, conducted in collaboration with universities and hospitals in other countries, will include both epidemiological studies and clinical trials for new vaccines or therapeutic approaches. The support center managed by FHI will assist with study design, protocol development, case report form construction, coordination of research team conference calls and meetings, data management and statistical analysis.

"Clinical research in developing countries encounters many unique challenges," said Kenneth F. Schulz, PhD, FHI Vice President for Quantitative Sciences, who will head the center. "FHI has a well-established legacy of successfully navigating these challenges in ways that are creative, effective and culturally-sensitive."

An important long-term goal for FHI's center will be helping scientists in other countries to improve their capabilities for conducting, managing and analyzing clinical research projects. FHI will also ensure that research complies with U.S. Food and Drug Administration "good clinical practices" guidelines and other scientific, ethical and fiscal standards. For example, the center's staff will work with in-country institutional review boards to assure proper review and approval of protocol and informed consent forms.

"We are very pleased that NIAID has selected Family Health International to support this worldwide network of research involving malaria, tuberculosis and other serious infectious diseases," said Willard Cates, Jr., MD, MPH, FHI President, who announced the selection today. "Our decades of experience in international study design, operations, monitoring and data management and analysis make FHI uniquely suited and qualified to support this challenging work."

At least 500 million people worldwide (one person in every 10) are infected with one or more of five major tropical parasitic diseases: malaria, schistosomiasis, filariasis, trypanosomiasis and leishmaniasis. Bacterial, viral and fungal infections in tropical regions also result in tuberculosis, diarrhea, hepatitis, acute respiratory infections, and hemorrhagic fevers. Children are disproportionately affected by these infections due to their immature immune systems and concurrent malnutrition.

The new center joins several large government projects conducted by FHI. Last fall, NIAID selected FHI to head a five-year network of research universities and institutions that are evaluating HIV prevention interventions in the United States and in developing countries. In December, the U.S. Agency for International Development (USAID) awarded FHI a five-year agreement to continue contraceptive research and related reproductive health projects. And in 1998, USAID selected FHI to oversee USAID's Implementing AIDS Prevention and Care (IMPACT) Project, a five-year program in more than 30 developing countries to prevent the spread of HIV/AIDS and provide care for those who are HIV infected.

Based in North Carolina, FHI has more than 400 employees worldwide and offices in 20 countries. In addition to its nonprofit work for government agencies and private foundations, FHI's affiliate, PharmaLink, provides global clinical research services to the pharmaceutical industry.