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. 2014 Mar 12;6(227):227fs11.
doi: 10.1126/scitranslmed.3008043.

Meeting the demand for pediatric clinical trials

Edward M Connor  1 , William E Smoyer, Jonathan M Davis, Anne Zajicek, Linda Ulrich, Mary Purucker, Steven Hirschfeld
Affiliations

Meeting the demand for pediatric clinical trials

Edward M Connor et al. Sci Transl Med. .

Abstract

High-quality, cost-effective pediatric clinical trials require a robust research and regulatory infrastructure and a properly trained workforce.

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Conflict of interest statement

Competing interests: E. M. C. serves as a consultant for Prosensa, Sarpeta, NEA, 3-V Biosciences, and Janssen and as CEO/CMO of ReveraGen.

References

    1. Connor E, Lombardi D, van den Anker J. More than baby steps: Perspectives on pediatric translational research. Sci Transl Med. 2009;1:2cm2. - PubMed
    1. Ioannidis JPA. Why most published research findings are false. PLOS Med. 2005;2:e124. - PMC - PubMed

    1. 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://video-cast.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.

    1. IOM CTSA report. www.iom.edu/Reports/2013/The-CTSA-Program-at-NIH-Opportunities-for-Advan....
    1. Enpr-EMA. www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general....

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