Clinical Research

FHI's Clinical Research Experience
FHI is experienced in every aspect of pharmaceutical product development, from preclinical through phase IV trials, and has conducted more than 500 clinical trials related to new and existing therapies and products. In collaboration with our global networks and partner organizations, FHI designs, implements, manages, and supports complex studies, including multisite and multicountry clinical trials. We hold multiple investigational new drug applications (INDs), have experience with investigational device exemptions (IDEs), and interact routinely with the US Food and Drug Administration (FDA). FHI's clinical research staff in Southeast Asian and African countries have expertise spanning multiple therapeutic areas.

FHI has conducted pivotal clinical trials of a number of new contraceptive products and helped prepare FDA submissions that led to product approval. We are currently involved in multiple Phase I, II, and III trials of products for prevention of HIV and other infectious diseases and for contraception.

In addition to our research, we collaborate with scientists from universities and research organizations throughout the United States and world. For more than a decade, FHI has been the operations center for the US National Institutes of Health (NIH) international HIV Prevention Trials Network. Studies focus on HIV prevention interventions, including antiretroviral therapy, microbicides, control of other sexually transmitted infections, behavior change, and interventions targeting substance use and mother-to-child transmission.

FHI serves as the coordinating center for the clinical trials conducted through the NIH Center for HIV/AIDS Vaccine Immunology (CHAVI). In this capacity, FHI leads the development of protocols and implementation at sites globally.

For close to 10 years, FHI has managed the NIH International Clinical Studies Support Center (ICSSC), providing training and technical assistance to scientists in resource-constrained countries undertaking research in tropical diseases. Additional activities include site assessments and training on clinical research methods, data management, biostatistics, research ethics, and scientific writing.

FHI also manages the NIH Center for International Research Assistance and Support (CIRAS) that focuses on conducting clinical research on emerging infectious diseases such as avian influenza. FHI currently manages Phase II and III multisite clinical trials in Africa and Asia evaluating new malaria therapeutics for children and adults and treatments for severe influenza.

For further information, contact services@fhi.org