While research frequently overlooks the unique needs of pediatric populations, Westat understands that children and teens are not yet adults and their responses to treatments can vary significantly. We work with sponsors to design studies for specific age groups to help advance solutions for the prevention and treatment of pediatric diseases and disorders. These can significantly increase survival rates and improve quality of life for children, adolescents, and their families. In particular, Westat is committed to collaborating with research teams to advance pediatric and adolescent vaccines and disease treatments through cutting-edge research.

Experience Across Generations

Westat’s multidisciplinary team possesses 30+ years of experience supporting pediatric and adolescent clinical studies, from early-phase pharmacokinetic/pharmacodynamic safety studies, to later-phase efficacy studies —and all steps in between. For example, when the Zika virus emerged, significantly impacting the health of children, Westat responded quickly to provide full-service support to research teams to design, manage, monitor, and provide statistical analysis expertise for studies investigating adverse maternal/fetal outcomes and the effects of the virus on the long-term growth and development of children.

A Trusted Legacy of Impactful Studies

Since 1987, Westat has been the contractor to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), providing logistical, technical, and administrative support to maintain, coordinate, and manage a multi-site network of domestic and international sites that conduct research on treatment, prevention, diagnosis, epidemiology, and natural history of HIV infection and disease.

Our work with NICHD includes creating studies to address data gaps for adolescent populations at high risk for HIV, including creation of a unique study (and full-service support for it) focusing on the use of HIV Pre-Exposure Prophylaxis (PrEP) in 15-17 year-olds. The study’s results were instrumental in the sponsor obtaining FDA approval for the use of PrEP by adolescents.

Westat provided support for Phase I, Phase I Follow-On and Phase III clinical trials for a novel gene therapy to treat children with an inherited form of vision loss that may result in blindness. It was the first U.S. approved, directly administered gene therapy targeting a disease caused by mutations in a specific gene. Westat played an integral role in assisting the sponsor in preparation for the FDA advisory committee meeting, resulting in the FDA voting unanimously to approve the Biologics License Application.

Westat also supported Phase I through Phase IV clinical trials for a drug to treat children with infections caused by gram positive pathogens.

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