Patient-Centered Outcomes Research: Stakeholder Perspectives and Ethical and Regulatory Oversight Issues.
作者信息
Largent Emily A, Weissman Joel S, Gupta Avni, Abraham Melissa, Rozenblum Ronen, Lynch Holly Fernandez, Cohen I Glenn
机构信息
Research Associate, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School.
Center for Surgery and Public Health, Brigham and Women's Hospital.
出版信息
IRB. 2018 Jan-Feb;40(1):7-17.
Abstract
摘要
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1
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2
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3
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4
Central institutional review board review for an academic trial network.
Acad Med. 2015 Mar;90(3):321-3. doi: 10.1097/ACM.0000000000000562.
5
Launching PCORnet, a national patient-centered clinical research network.
J Am Med Inform Assoc. 2014 Jul-Aug;21(4):578-82. doi: 10.1136/amiajnl-2014-002747. Epub 2014 May 12.
6
Ethics and regulatory complexities for pragmatic clinical trials.
JAMA. 2014 Jun 18;311(23):2381-2. doi: 10.1001/jama.2014.4164.
7
PCOR, CER, and CBPR: alphabet soup or complementary fields of health research?
Clin Transl Sci. 2013 Dec;6(6):493-6. doi: 10.1111/cts.12064. Epub 2013 May 8.
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Am J Public Health. 2013 Dec;103(12):e7-e14. doi: 10.2105/AJPH.2013.301605. Epub 2013 Oct 17.
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Network news: powering clinical research.
Sci Transl Med. 2013 Apr 24;5(182):182fs13. doi: 10.1126/scitranslmed.3006298. Epub 2013 Apr 23.
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PLoS Med. 2013;10(2):e1001382. doi: 10.1371/journal.pmed.1001382. Epub 2013 Feb 12.
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