Program staff seeks Council approval for an initiative titled “Integrative Research Resources for Advancing Maternal & Pediatric Therapeutics”.
Enabled by legislations such as PREA and BPCA, progress has been made in our understanding of pediatric pharmacology and therapeutics, although significant knowledge gaps remain.
Pregnant and lactating women have been even more of a “therapeutic orphan” than children have, due to the concerns about conducting drug research/trials in such “high-risk” and “vulnerable” populations. Despite the “Common Rule” recently removed pregnant women from the “vulnerable” population classification, pregnant and lactating women are still excluded from most of the early drug treatment trials and drug/vaccine development process which could lead to missed opportunities to identify efficacious and safe treatments to prevent adverse maternal, pregnancy, and birth outcomes. Health care providers and patients often face dilemmas and challenges when making treatment decisions in the absence of sufficient safety data for pregnant and lactating women. Pregnant and lactating women should be protected through research rather than from research.
The PRGLAC recommendations suggest that a proactive plan for including pregnant and lactating women could be developed before implementing clinical trials. Novel systematic infrastructure for research and resource generation will be essential to support the expertise and resource needed to foster and conduct innovative therapeutics-focused research and clinical trials in pregnant and lactating women as well as children. This newly established infrastructure will be scalable and transformable to enable innovative research designs for therapeutic studies in response to emerging needs.
In addition, there is a great need of a complementary training and career development program that feeds the pipeline of experts in the fields of maternal and pediatric pharmacology and therapeutics. The increased availability of training opportunities and research efforts would address these challenges, simultaneously embracing maternal and pediatric pharmacology initiatives.
The overarching goals of this initiative are to: (1) Establish systematic research infrastructure to foster and conduct research and generate resources advancing maternal and pediatric therapeutics; (2) create a complementary training and career development program addressing an urgent need to increase the number of scientists and clinicians trained in maternal and pediatric clinical pharmacology and therapeutics.
This initiative will expand the efforts of the newly awarded Maternal and Pediatric Precision in Therapeutics (MPRINT) hub, and leverage the existing resources of PTN, and work with future NICHD-supported clinical trials networks to advance maternal and pediatric therapeutics.
This proposed concept aligns with the NICHD Strategic Plan Theme Five “Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities” as well as Themes 2 and 3, Cross Cutting goal of Health Disparities, and Scientific Stewardship through “Promoting an Inclusive Scientific Workforce That Fosters Research Training”.
This proposed concept addresses PRGLAC recommendations 2, 3, 8, 10, 11, and 13. This proposed concept addresses BPCA recommendations to support research and training and career development in pediatric pharmacology and therapeutics. This proposed concept also addresses OPPTB program priority.
Program Contact
Zhaoxia Ren
Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)
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