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  1. An Ethical Analysis of the SUPPORT Trial: Addressing Challenges Posed by a Pragmatic Comparative Effectiveness Randomized Controlled Trial.Austin R. Horn, Charles Weijer, Jeremy Grimshaw, Jamie Brehaut, Dean Fergusson, Cory E. Goldstein & Monica Taljaard - 2018 - Kennedy Institute of Ethics Journal 28 (1):85-118.
    Pragmatic comparative effectiveness randomized controlled trials evaluate the effectiveness of one interventions under real-world clinical conditions. The results of ceRCTs are often directly generalizable to everyday clinical practice, providing information critical to decision-making by patients, clinicians, and healthcare policymakers. The PRECIS-2 framework identifies nine domains that serve to score a trial on a continuum between very explanatory to very pragmatic. According to the framework, pragmatic trials may have one or more of the following features: there are fewer eligibility criteria for (...)
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  • Response to Open Peer Commentaries on “Misrepresenting ‘Usual Care’ in Research: An Ethical and Scientific Error”.Ruth Macklin & Charles Natanson - 2020 - American Journal of Bioethics 20 (1):W12-W14.
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  • Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error.Ruth Macklin & Charles Natanson - 2020 - American Journal of Bioethics 20 (1):31-39.
    ABSTRACTComparative effectiveness studies, referred to here as “usual-care” trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains “unusual” care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, (...)
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