title: Clinical Translation of the National Institutes of Health's Investments in Nanodrug Products and Devices.
abstract: The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting biomedical research. The NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability. In support of this mission, NIH has invested about $4.4 billion since 2001 in nanotechnology (NT) research. This investment is leading to fundamental changes in understanding biological processes in health and disease, as well as enabling novel diagnostics and interventions for treating disease. NIH scientists are developing molecular agents and methods for earlier and more accurate diagnosis and therapies aimed directly and selectively at diseased cells, and are exploring root causes of common and rare diseases at the nanoscale. Work is also underway to move these research tools and devices into clinical practice. This particular investigative review examines the NIH NT portfolio linked to clinical trials from FY2008 to FY2015 to assess the progress of clinical translation. Among the subset of trials identified, 70% target drug or combination drug-device products used in treating cancer, AIDS, and other various diseases. The review also provides insight into trends observed from studying the clinical research portfolio.
authors.affiliation: Diagnostic Imaging Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, Maryland, 20850, USA. hendersonlori@mail.nih.gov.
authors.forename: Lori A
authors.initials: LA
authors.lastname: Henderson
authors.affiliation: Diagnostic Imaging Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, Maryland, 20850, USA.
authors.forename: Lalitha K
authors.initials: LK
authors.lastname: Shankar
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000458:organization & administration*; D002986:Clinical Trials as Topic / Q000191:economics; D006801:Humans; D036103:Nanotechnology; D009316:National Institutes of Health (U.S.) / Q000191:economics / Q000458:organization & administration*; D012109:Research Support as Topic; D057170:Translational Research, Biomedical / Q000191:economics / Q000458:organization & administration; D014481:United States
keywords: clinical trials; devices; nanodrugs; nanomedicine; nanotechnology