Clinical trials, population health, and epidemiological research projects, such as case-control or cohort studies, typically generate data with utility beyond the specific hypotheses and questions for which they were originally designed. Expanded use of secondary analysis of existing data sets and biorepositories allows researchers to address research questions within the scientific scope of the NICHD at relatively low cost and effort and enhances the value of NICHD investments in research. Electronic linkages across data sets/biospecimens or with administrative data bases, such as electronic health records, will expand the scope and impact of research on child health and human development.
To date, a major barrier to secondary analysis has been limited availability of data and biospecimens and inadequate documentation of archived materials. As NIH and NICHD increase the availability of data to the scientific community this barrier is diminished.
This initiative will support secondary analyses of NICHD-supported data as well as data that can advance the scientific priorities of NICHD extramural branches, including but not limited to:
- Physiological factors affecting change (e.g., endocrine, musculoskeletal health, reproductive health, intellectual function, and behaviors) at different points in the life span, including factors contributing to health and healthy development across the life course;
- Determinants, including genetic determinants, of health, human development, disability, and disease in conditions of interest to the NICHD;
- How positive and negative risk factors for health, health behaviors, and healthy development differ by age;
- How positive and negative risk factors differ for health and developmental outcomes differ across stages of disease or condition progression, and/or in the presence or absence of co-existing conditions;
- Early exposures and conditions, including those experienced prenatally and or by prior generations, that influence health, development, or risk of disease and injury in later life, including later in childhood, adolescence, and young adulthood;
- Long-term effects of interventions aimed at addressing conditions related to health, development, disability, or injury, including both the long-term effects on the targeted condition itself and other health-related outcomes;
- Health effects, direct and/or indirect, resulting from exposure to a traumatic event or chronic and persistent exposure to trauma;
- How alternative treatment regimens or health care management strategies influence the effectiveness and safety of treatment;
- How the effects of interventions in clinical trials differ by age, race, gender, disability, or other factors;
- Exploratory analysis, including assays on stored biospecimens, to explore effects of interventions on additional outcomes;
- Analysis and meta-analysis of existing data sets to inform designs of future clinical trials (e.g., to determine prevalence of a disease or condition, or a combination of conditions in a population of interest; to estimate effects size of an intervention and duration of treatment in a population of interest, etc.);
- Analysis or meta-analysis of existing data sets to explore opportunities for and determine the need for comparative effectiveness clinical trials in a topic area;
- Methodology development: Single or multiple data sets may be used to develop and test new analytic approaches for any of the above topics;
- Natural history studies of rare or common disorders or conditions that may inform stratification of cohorts for biomarker discovery or development of treatments or interventions;
- Identifying biomarkers of disease or injury progression, functional impairment, treatment response, and functional recovery;
- Environmental factors that support or challenge health maintenance and/or recovery following injury or illness;
- Analyses defining outcomes related to disability or injury effective at different time points after onset;
- Pharmacokinetics analysis of existing data sets that will help improve pharmacotherapy for neonatal and pediatric populations;
- Genotyping utilizing existing samples to assist in pediatric personalized medicine;
- Genotype-phenotype correlations based on existing data and samples to assist setting up primary outcomes for pediatric clinical trials;
- Analysis of maternal blood or imaging data to establish differences between normal versus pathological placental development and/or function across pregnancy.
Deadlines: Standard dates and standard AIDS dates apply
URL: https://grants.nih.gov/grants/guide/pa-files/PA-17-299.html
Filed Under: Funding Opportunities