A renewal of a Request for Applications (RFA) entitled “Obstetric-Fetal Pharmacology Research Units (OPRU) Network” using a cooperative agreement grant mechanism is proposed.
The purpose of this RFA is to promote and maintain a multicenter research network of obstetric-fetal pharmacology units to conduct basic mechanistic, translational and clinical studies of therapeutic drugs used in pregnant women. The RFA will solicit new and renewal applications to participate in the OPRU network.
The OPRU network was initially established in 2004 to address an unmet medical need, that therapeutic drugs used to treat pregnant women should be systematically studied in pregnant women to achieve desired dosing, efficacy and safety. The OPRU network has empowered clinical scientists and basic science investigators to collaborate, and provided critical research infrastructure for pharmacokinetic, pharmacodynamic, and pharmacogenomic studies of drugs used during pregnancy. For the past nine years, the OPRU network has made significant progress in many areas and published more than 90 peer-reviewed articles covering basic, translational clinical studies. Some of the pivotal results have potential implications on changing clinical practice and drug labeling.
The OPRU network will: (1) perform studies of fetal, placental and maternal pharmacology, including evaluation of the effects of pregnancy and pharmacogenomics on drug metabolizing enzymes, transporters and their associated signaling pathways; (2) assess maternal and fetal outcome measures of drug exposure during pregnancy.
The OPRU network will continue focusing on early phase 1 and 2 clinical trials and determine PK and/or PD of the drugs that are of therapeutic value during pregnancy and whose disposition and response are altered by the pregnant state in normal or abnormal pregnancies involving such conditions as gestational diabetes, hypertension, preeclampsia, and preterm birth. The causes of alteration in PK and/or PD during pregnancy will be elucidated by basic mechanistic studies.
The objective of the RFA is to foster a multi-center research network to identify innovative research strategies in obstetric pharmacology research, with ultimate goal of improving the safety and effectiveness of the drug treatment in pregnant women.
Zhaoxia Ren, MD, PhD
Obstetric and Pediatric Pharmacology and Therapeutics Branch
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