Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports

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Chang, L.
Dhruva, S. S.
Chu, J.
Bero, L. A.
Redberg, R. F.
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R5 [内科学];
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1002 ; 100201 ;
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页码:22 / 23
页数:2
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    Dhruva, Sanket S.
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    Bero, Lisa A.
    Redberg, Rita F.
    [J]. BMJ-BRITISH MEDICAL JOURNAL, 2015, 350
  • [2] Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study
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    Rathi, Vinay K.
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    [J]. JAMA INTERNAL MEDICINE, 2016, 176 (04) : 551 - 552
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