202001 Multi-site Clinical Trial Infrastructure in Pregnancy and Lactation

Program seeks Council approval for an initiative to provide critically needed infrastructure to support multi-site clinical trials in pregnancy and lactation. The conduct of rigorous clinical trials in obstetrics and lactation is critical for establishing clinical guidelines that impact care and improve the lives and safety of pregnant women and their offspring. 

Historically, pregnant and lactating women have been routinely excluded from participation in clinical trials of drugs and other therapeutics and treatments.  The congressionally established Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), led by NICHD, found that there is a cavernous gap in knowledge when it comes to the evidence-based practice of drug and medication use in pregnancy and lactation and that “research on therapies [for pregnant and lactating women] must be facilitated and greatly augmented.”  (Report to the Secretary and Congress, September 2018, p. 4) 

The goal of this initiative is to establish a robust infrastructure for the conduct of multicenter phase 0-3 clinical trials of interventions, drugs, devices, and other therapeutics for use by pregnant and lactating women.  This infrastructure will include a data and clinical coordinating center and multiple affiliated clinical centers.  By creating this infrastructure, NICHD will provide an infrastructure resource that will be available to the research community to support rigorous conduct of high-quality multi-site clinical trials in pregnancy and lactation.

Sustaining an ability to conduct multicenter clinical trials of interventions and therapeutics in large, diverse populations, establishing this infrastructure directly addresses the PPB priorities of stillbirth, diabetes during pregnancy, preterm birth, and perinatal health disparities.  The program will also address two major themes in the strategic plan of “Setting the Foundation for Healthy Pregnancies and Lifelong Wellness” and “Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities.”

Program Contact

Caroline Signore
Pregnancy and Perinatology Branch (PPB)

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