Low risk pragmatic trials do not always require participants' informed consent (vol 364, l1092, 2019)

Rafael Dal-Re,Cristina Avendano-Sola,Brigitte Bloechl-Daum,Anthonius de Boer,Stefan Eriksson,Uwe Fuhr,Soren Holm,Stefan K. James,Robert J. Mentz,Emilio Perucca,Frits R. Rosendaal,Shaun Treweek

BMJ-BRITISH MEDICAL JOURNAL（2019）

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摘要

Clinical trial regulations should remove unnecessary obstacles for the conduct of pragmatic trials assessing the comparative effectiveness of medicines posing no or minimal risk to participants, say Rafael Dal-Re and colleagues

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关键词

pragmatic trials,informed consent,low risk,participants

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