Low risk pragmatic trials do not always require participants’ informed consent

Rafael Dal-Re (Corresponding Author), Cristina Avendaño-Solà, Brigitte Bloechl-Daum, Anthonius de Boer, Stefan Eriksson, Uwe Fuhr, Søren Holm, Stefan K. James, Robert J. Mentz, Emilio Perucca, Frits R. Rosendaal, Shaun Treweek

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Abstract

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-Ré and colleagues
Original languageEnglish
Article number1092
Number of pages8
JournalBMJ
Volume364
DOIs
Publication statusPublished - 27 Mar 2019

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Keywords

  • CLINICAL-TRIALS

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Dal-Re, R., Avendaño-Solà, C., Bloechl-Daum, B., de Boer, A., Eriksson, S., Fuhr, U., ... Treweek, S. (2019). Low risk pragmatic trials do not always require participants’ informed consent. BMJ, 364, [1092]. https://doi.org/10.1136/bmj.l1092