RTI International (RTI) proposes to establish the Data Coordinating and Analysis Center (DCAC) for the Obstetrical Pharmacology Research Network (OPRU). RTI's 31 years of experience serving as DCAC for over 25 multi-site clinical, epidemiologic, and behavioral studies, many in the field of maternal and child health, enable us to recognize and address the various responsibilities that must be undertaken by a DCAC to successfully meet the ever-changing needs of a multi-site study. The OPRU DCAC has several unique requirements: (1) the DCAC will integrate into an operational Network with multiple ongoing protocols, (2) the biospecimens collected include unusual tissues such as placenta and cord blood, and (3) some data may be submitted to the FDA in support of drug labeling, which has implications for quality assurance and control in the protocols. Of particular note, the research involves the opportunity to advance the field of pharmacokinetic and pharmacodynamic modeling. Consequently, we propose key persons with experience in DCAC projects, as well as statistical modeling and animal and clinical research. We propose Dr. Rick Williams as PI (DCAC management and statistical modeling) and Co-Investigators Drs. Timothy Fennell (animal toxicology) and Claude Hughes (clinical trial and translational medicine) from RTI and Dr. Edmund Capparelli (pediatric pharmacokinetic analysis) at the U of California, San Diego. Other responsibilities for the DCAC include, but are not limited to: (1) participating in protocol development;(2) developing and implementing a study-wide communications network;(3) providing data collection and management systems that are responsive to the emerging needs of the study;(4) supporting the logistics of the study as needed;(5) assisting in training site personnel in standard study procedures;(6) assisting in developing and implementing quality control and quality assurance procedures;(7) supporting the collection, shipping, and tracking of biospecimens;(8) providing biostatistical and data management leadership;(9) producing both routine and ad hoc reports that meet the needs of the Research Sites, the Steering Committee, and the Data Safety and Monitoring Board;and (10) helping to disseminate the results of the study through publications and presentations within the context of a coordinated dissemination plan. As the demands of the Network change, we will be able to supplement our base staff with needed expertise from our large staff with varied backgrounds that address the anticipated needs of the study. RTI's office near to NICHD in Rockville, MD, provides meeting space as needed for interaction and local support for Steering Committee meetings.
|Costantine, Maged M; Cleary, Kirsten; Hebert, Mary F et al. (2016) Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial. Am J Obstet Gynecol 214:720.e1-720.e17|
|Cleary, Kirsten Lawrence; Roney, Kelly; Costantine, Maged (2014) Challenges of studying drugs in pregnancy for off-label indications: pravastatin for preeclampsia prevention. Semin Perinatol 38:523-7|
|Costantine, Maged M; Cleary, Kirsten; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric--Fetal Pharmacology Research Units Network (2013) Pravastatin for the prevention of preeclampsia in high-risk pregnant women. Obstet Gynecol 121:349-53|
|Haas, David M; Quinney, Sara K; Clay, Jayanti M et al. (2013) Nifedipine pharmacokinetics are influenced by CYP3A5 genotype when used as a preterm labor tocolytic. Am J Perinatol 30:275-81|