Meeting the Demand for Pediatric Clinical Trials

Author:

Connor Edward M.1,Smoyer William E.2,Davis Jonathan M.3,Zajicek Anne4,Ulrich Linda5,Purucker Mary6,Hirschfeld Steven4

Affiliation:

1. Department of Pediatrics and Clinical and Translational Science Institute, Children’s National Medical Center; and School of Medicine and Health Sciences, George Washington University, Washington, DC 20010, USA.

2. Center for Clinical and Translational Research, The Research Institute at Nationwide Children’s Hospital, and the Department of Pediatrics, The Ohio State University, Columbus, OH 43205, USA.

3. Department of Pediatrics and Tufts Clinical and Translational Science Institute, The Floating Hospital for Children at Tufts Medical Center, Boston, MA 02111, USA.

4. The Eunice Kennedy Shriver NICHD, Bethesda, MD 20892, USA.

5. Office of Orphan Products Development, FDA, Silver Spring, MD 20993, USA.

6. CTSA, NCATS, Bethesda, MD 20892, USA.

Abstract

The bid for high-quality, cost-effective pediatric clinical trials requires robust research and regulatory playgrounds and an appropriately trained workforce.

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

Reference8 articles.

1. Connor E. Lombardi D. van den Anker J. More than baby steps: Perspectives on pediatric translational research. Sci. Transl. Med . 1 2cm2 (2009).

2. Why Most Published Research Findings Are False

3. CTSA pediatric data-quality workshops: “Pediatric drug and medical device development: Setting specifications and defining expectations”; “Quality data for pediatric clinical trials”; and “Bridging the terminology gap in pediatrics: Developing an action plan to support the continuum from clinic to research.” http://nihvideoidol1.cit.nih.gov:8080/NIH/widgets/hyperlinking/autosuggest.jsp?seconds=0&filetype=FLASH&realplayer=http://videocast.nih.gov/flashvod.xml?id=10719&offset=0&url=http%3A%2F%2Fvideocast.nih.gov%2FSummary.asp%3FFile%3D16923&id=10719&links=PEDIATR CTSA CONSORTIUM&v=c&fileid=16923&q=%28pediatrics%29+AND+%28CTSA+Consortium%29.

4. IOM CTSA report. www.iom.edu/Reports/2013/The-CTSA-Program-at-NIH-Opportunities-for-Advancing-Clinical-and-Translational-Research.aspx.

5. Enpr-EMA. www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000303.jsp&mid=WC0b01ac05801df74a.

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