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1.  We Don’t Know What We Don’t Study: The Case for Research on Medication Effects in Pregnancy 
This Commentary addresses issues related to exposures to teratogens and makes the case for increased research into the safety of medications during pregnancy for mothers and fetuses. Not only are medications commonly used during pregnancy, but evidence points to an increasing prevalence and number of drug exposures experienced by the embryo or fetus, particularly during the critical first trimester of pregnancy. Although the first trimester represents a particularly vulnerable period of organogenesis, exposures during other gestational time periods may also be associated with deleterious outcomes. In addition to the changing (and in many cases unknown) risks to a developing fetus, other challenges to studying medication exposures and their effects during pregnancy include the dramatic changes in physiology that occur in pregnant women and the ethical dilemmas posed by including this vulnerable population in randomized controlled trials of safety and efficacy. However, without adequate knowledge of the pharmacokinetics, pharmacodynamics, efficacy, and safety of medication use in pregnancy, women may be under-dosed to minimize exposure or not treated at all, resulting in inadequate treatment and potential harm to the mother and her baby. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is undertaking studies on medications and teratogenic exposures during pregnancy, including alcohol, maternal diabetes, oral hypoglycemic agents, and antiviral medications, through several of its research networks. Although this is a start, there is a critical need for further research on medications used during pregnancy, especially their effects on both the mother and her developing child.
PMCID: PMC3140632  PMID: 21766436
medication; exposure; pregnancy; teratogen; research
The National Children’s Study (NCS) will examine the effects of the environment and genetics on the growth, development and health of children across the United States; it will follow participants from before birth until age 21 years. The goal of the Study is to improve the health and well-being of children and contribute to understanding the role various factors have on health and disease. Findings from the Study will be made available as the research progresses, making potential benefits known to the public as soon as possible.
A robust pilot or Vanguard Study is underway to generate data for designing the subsequent Main Study. The goals of the Vanguard Study are feasibility, acceptability and cost and the goals of the Main Study will be exposure-response relationships and biological, environmental and genetic interactions.
The initial Vanguard Study experience among 7 Study Centers was successful in many ways including delineating the topics to explore for the next phase of the Vanguard Study. Three different recruitment strategies are under evaluation to determine what approach to use for the Main Study. The organization of NCS operations is currentlybased on a new decentralized business model.
PMCID: PMC3247064  PMID: 21259268
3.  Commentary: Trailblazing a Research Agenda at the Interface of Pediatrics and Genomic Discovery—a Commentary on the Psychological Aspects of Genomics and Child Health 
Journal of Pediatric Psychology  2009;34(6):662-664.
Unprecedented advances in human genome science are underway with potential to benefit public health. For example, it is estimated that within a decade, geneticists and epidemiologists will complete a catalog of the majority of genes associated with common chronic diseases. Such rapid advances create possibilities, if not the mandate, for translational research in how best to apply these and other anticipated discoveries for both individual and population health benefit. Driving these discoveries are rapid advances in infrastructure (e.g., the International HapMap Project to catalog human genetic variation;, analytical methods, and technology. This expansion in capabilities quickly has taken us from a genetics paradigm—where the influence of individual genes on health outcomes is paramount, to a genomics paradigm—where the complex influence of individual genes is considered in concert with each other and with environmental exposures on health outcomes. We discuss these and similar groundbreaking discoveries with an eye toward understanding their importance to child health and human development, and the role of behavioral science research conducted at the interface of pediatrics and genomic discovery.
PMCID: PMC2722104  PMID: 19129267
4.  Finding the missing heritability of complex diseases 
Nature  2009;461(7265):747-753.
Genome-wide association studies have identified hundreds of genetic variants associated with complex human diseases and traits, and have provided valuable insights into their genetic architecture. Most variants identified so far confer relatively small increments in risk, and explain only a small proportion of familial clustering, leading many to question how the remaining, ‘missing’ heritability can be explained. Here we examine potential sources of missing heritability and propose research strategies, including and extending beyond current genome-wide association approaches, to illuminate the genetics of complex diseases and enhance its potential to enable effective disease prevention or treatment.
PMCID: PMC2831613  PMID: 19812666

Results 1-4 (4)