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Clinical Research

Clinical research and genomic research will overlap in studies that attempt to determine the interaction between genetic make-up, behavioral and environmental risk factors, disease resistance, drug response, and clinical outcomes. Clinical trials that would have been limited to a small number of academic centers will be carried out in partnership among organized patient communities, community-based health care providers, and academic researchers. These teams collectively will care for groups of well-characterized patients that are large enough to reliably predict whether new interventions are safe and effective. They will be able to do work that required physical collocation in the past – using robust, standards-based clinical research infrastructure which began to emerge in 2005 as a result of the NIH Roadmap.

This 21st century approach will leverage electronic records used for health care and public health reporting and employ new ways to capture clinical research data, standards for clinical research protocols, new models of cooperation between NIH and patient advocacy alliances, and new strategies to strengthen the clinical research workforce. Standard clinical research infrastructure will facilitate the production of comprehensive registries of clinical trials and more prompt and thorough reporting of their results.