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  1.  35
    Policy on Synthetic Biology: Deliberation, Probability, and the Precautionary Paradox.Christopher Wareham & Cecilia Nardini - 2013 - Bioethics 29 (2):118-125.
    Synthetic biology is a cutting-edge area of research that holds the promise of unprecedented health benefits. However, in tandem with these large prospective benefits, synthetic biology projects entail a risk of catastrophic consequences whose severity may exceed that of most ordinary human undertakings. This is due to the peculiar nature of synthetic biology as a ‘threshold technology’ which opens doors to opportunities and applications that are essentially unpredictable. Fears about these potentially unstoppable consequences have led to declarations from civil society (...)
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  2.  39
    Mechanistic understanding in clinical practice: complementing evidence‐based medicine with personalized medicine.Cecilia Nardini, Marco Annoni & Giuseppe Schiavone - 2012 - Journal of Evaluation in Clinical Practice 18 (5):1000-1005.
  3.  68
    Bias and Conditioning in Sequential medical trials.Cecilia Nardini & Jan Sprenger - 2013 - Philosophy of Science 80 (5):1053-1064.
    Randomized Controlled Trials are currently the gold standard within evidence-based medicine. Usually, they are conducted as sequential trials allowing for monitoring for early signs of effectiveness or harm. However, evidence from early stopped trials is often charged with being biased towards implausibly large effects. To our mind, this skeptical attitude is unfounded and caused by the failure to perform appropriate conditioning in the statistical analysis of the evidence. We contend that a shift from unconditional hypothesis tests in the style of (...)
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  4.  61
    Monitoring in clinical trials: benefit or bias?Cecilia Nardini - 2013 - Theoretical Medicine and Bioethics 34 (4):259-274.
    Monitoring ongoing clinical trials for early signs of effectiveness is an option for improving cost-effectiveness of trials that is becoming increasingly common. Alongside the obvious advantages made possible by monitoring, however, there are some downsides. In particular, there is growing concern in the medical community that trials stopped early for benefit tend to overestimate treatment effect. In this paper, I examine this problem from the point of view of statistical methodology, starting from the observation that the overestimation is caused by (...)
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    The ethics of non-inferiority trials: A consequentialist analysis.Marco Annoni, Virginia Sanchini & Cecilia Nardini - 2013 - Research Ethics 9 (3):109-120.
    Discussions about the merits and shortcomings of non-inferiority trials are becoming increasingly common in the medical community and among regulatory agencies. However, criticisms targeting the ethical standing of non-inferiority trials have often been mistargeted. In this article we review the ethical standing of trials of non-inferiority. In the first part of the article, we outline a consequentialist position according to which clinical trials are best conceived as epistemic tools aimed at fostering the proper ends of medicine. According to this view, (...)
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    What Kind of Principle Is Clinical Equipoise?Luca Chiapperino & Cecilia Nardini - 2014 - Theoretical and Applied Ethics 3 (1):1-16.
    Equipoise, or the criterion of honest professional uncertainty in the clinical community, is currently the most widely accepted standard for adjudicating the ethical dilemmas of medical research involving human patients. Nonetheless, equipoise has recently become a subject of considerable criticism. Among the objections to equipoise, an important one is based on the observation of an objective difficulty for equipoise in providing sound ethical guidance in practical circumstances that arise in clinical research. A chief example of such problem is represented by (...)
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