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  1. Are explanatory trials ethical? Shifting the burden of justification in clinical trial design.Kirstin Borgerson - 2013 - Theoretical Medicine and Bioethics 34 (4):293-308.
    Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some (...)
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  • Response to Open Peer Commentaries on “The Case for Evidence-Based Rulemaking”.Benjamin Sachs - 2010 - American Journal of Bioethics 10 (6):1-3.
    Here I inquire into the status of the rules promulgated in the canonical pronouncements on human subjects research, such as the Declaration of Helsinki and the Belmont Report. The question is whether they are ethical rules or rules of policy. An ethical rule is supposed to accurately reflect the ethical fact, whereas rules of policy are implemented to achieve a goal. We should be skeptical, I argue, that the actions prescribed by the rules are ethically obligatory, and consequently we should (...)
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