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About the OPRC

The OPRC program was established by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in 2004. Since then several different academic institutions and medical facilities have participated. See History for more information.

Our goal is to obtain information regarding drug safety, efficacy (how well they work) and optimal dosing during pregnancy and while breastfeeding. Most OPRC studies include a component to understand the movement of drugs into, through and out of the body during pregnancy (pharmacokinetics (PK)) as well as the effects of the drug to the fetus and mother (pharmacodynamics (PD)). Our team of experts will incorporate influences of genetics and the environment into research models with the objective of informing the medical community and improving clinical care for the mother and her baby.

Our multi-disciplinary team includes expert physicians, scientists and researchers from across the United States. The OPRC program is comprised of the study sponsor (NICHD), several Centers, a Logistic Coordinating Core (LCC) and an independent Data Monitoring Committee. Each Center recruits, treats and follows study participants and supports research led by a Principal Investigator and Administrative Core. The LCC provides regulatory oversight and administrative support for the OPRC program. The Data Monitoring Committee is an external group assembled by the NICHD that is responsible for safeguarding the interests of study participants, assessing the safety and efficacy of all study procedures, assuring data quality and integrity, and monitoring the overall conduct of each study. Members of each organization serve as the governing board, or Steering Committee, and provide oversight to the OPRC. See Centers & Investigators for more information.

Centers work collaboratively on clinical studies across several therapeutic areas (e.g., preeclampsia, addictive behaviors, depression), but also lead independent basic/translational research projects (using animals or cells only) and pilot research projects (early stage, small number of patients participating). See Types of Studies, OPRC Protocols and OPRU Protocols for more information.