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.