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Profile: Roger Stanev (University of South Florida)
  1. Roger Stanev, Data and Safety Monitoring Board and the Ratio Decidendi of the Trial.
    Decision-making by a Data and Safety Monitoring Board (DSMB) regarding clinical trial conduct and termination is intricate and largely limited by cases and rules. Decision-making by legal jury is also intricate and largely constrained by cases and rules. In this paper, I argue by analogy that legal decision-making, which strives for a balance between competing demands of conservatism and innovation, supplies a good basis to the logic behind DSMB decision-making. Using the doctrine of precedents in legal reasoning as my central (...)
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  2. Roger Stanev (forthcoming). Early Stopping of RCTs: Two Potential Issues for Error Statistics. Synthese:1-28.
    Error statistics (ES) is an important methodological view in philosophy of statistics and philosophy of science that can be applied to scientific experiments such as clinical trials. In this paper, I raise two potential issues for ES when it comes to guiding, and explaining early stopping of randomized controlled trials (RCTs): (a) ES (via its severity principle) provides limited guidance in cases of early unfavorable trends due to the possibility of trend reversal; (b) ES is silent on how to prospectively (...)
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  3. Roger Stanev (2012). Ezekiel J. Emanuel, Christine C. Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, and David D. Wendler (Eds.): The Oxford Textbook of Clinical Research Ethics. [REVIEW] Theoretical Medicine and Bioethics 33 (3):221-226.
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  4. Roger Stanev (2012). Modelling and Simulating Early Stopping of RCTs: A Case Study of Early Stop Due to Harm. Journal of Experimental and Theoretical Artificial Intelligence 24 (4):513-526.
    Despite efforts from regulatory agencies (e.g. NIH, FDA), recent systematic reviews of randomised controlled trials (RCTs) show that top medical journals continue to publish trials without requiring authors to report details for readers to evaluate early stopping decisions carefully. This article presents a systematic way of modelling and simulating interim monitoring decisions of RCTs. By taking an approach that is both general and rigorous, the proposed framework models and evaluates early stopping decisions of RCTs based on a clear and consistent (...)
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  5. Roger Stanev (2012). Review of The Oxford Textbook of Clinical Research Ethics, by D. Wendler, C. Grady, R. Crouch, R. Lie, F. Miller, and E. Emanuel. Theoretical Medicine and Bioethics 33 (3):221-226.
    When is clinical research ethical? The difficulty in answering this question lies in the dual nature of research on human subjects, which yields two somewhat conflicting sets of obligations. On the one hand, there is the traditional view of science that includes the idea of an obligation to learn about the world. On the other hand, there is the obligation of care on the part of researchers towards individual participants in the research ...
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  6. Roger Stanev (2012). Stopping Rules and Data Monitoring in Clinical Trials. In H. W. de Regt, S. Hartmann & S. Okasha (eds.), EPSA Philosophy of Science: Amsterdam 2009, The European Philosophy of Science Association Proceedings Vol. 1, 375-386. Springer. 375--386.
    Stopping rules — rules dictating when to stop accumulating data and start analyzing it for the purposes of inferring from the experiment — divide Bayesians, Likelihoodists and classical statistical approaches to inference. Although the relationship between Bayesian philosophy of science and stopping rules can be complex (cf. Steel 2003), in general, Bayesians regard stopping rules as irrelevant to what inference should be drawn from the data. This position clashes with classical statistical accounts. For orthodox statistics, stopping rules do matter to (...)
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  7. Roger Stanev (2012). The Epistemology and Ethics of Early Stopping Decisions in Randomized Controlled Trials. Dissertation, University of British Columbia
    Philosophers subscribing to particular principles of statistical inference and evidence need to be aware of the limitations and practical consequences of the statistical approach they endorse. The framework proposed (for statistical inference in the field of medicine) allows disparate statistical approaches to emerge in their appropriate context. My dissertation proposes a decision theoretic model, together with methodological guidelines, that provide important considerations for deciding on clinical trial conduct. These considerations do not amount to more stopping rules. Instead, they are principles (...)
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  8. Roger Stanev (2011). Review of Justice and Health Care: Selected Essays, by Allen Buchanan. Theoretical Medicine and Bioethics 32 (2):137-142.
    Justice and Health Care: Selected Essays collects, in a systematic but non-chronological fashion, ten of Buchanan’s most significant essays on justice and health care, written over a period of almost three decades. As the Obama administration continues to struggle to implement much-needed comprehensive health care reform in the hopes of controlling rising health care costs and extending affordable health care to over 46 million uninsured Americans [1], there could hardly be a more appropriate time to read Buchanan’s selected essays ...
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  9. Roger Stanev (2011). Statistical Decisions and the Interim Analyses of Clinical Trials. Theoretical Medicine and Bioethics 32 (1):61-74.
    This paper analyzes statistical decisions during the interim analyses of clinical trials. After some general remarks about the ethical and scientific demands of clinical trials, I introduce the notion of a hard-case clinical trial, explain the basic idea behind it, and provide a real example involving the interim analyses of zidovudine in asymptomatic HIV-infected patients. The example leads me to propose a decision analytic framework for handling ethical conflicts that might arise during the monitoring of hard-case clinical trials. I use (...)
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  10. Roger Stanev (2009). Epidemiologic Causation: Jerome Cornfield’s Argument for a Causal Connection Between Smoking and Lung Cancer. Humana.Mente 9:59-66.
    A central issue confronting both philosophers and practitioners in formulating an analysis of causation is the question of what constitutes evidence for a causal association. From the 1950s onward, the biostatistician Jerome Cornfield put himself at the center of a controversial debate over whether cigarette smoking was a causative factor in the incidence of lung cancer. Despite criticisms from distinguished statisticians such as Fisher, Berkson and Neyman, Cornfield argued that a review of the scientific evidence supported the conclusion of a (...)
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  11. Peter Danielson, Alex Mesoudi & Roger Stanev (2008). Nerd and Norms: Framework and Experiments. Philosophy of Science 75 (5):830-842.
    We advocate and share the same theoretical framework for empirical research in ethics as exemplified in Christina Bicchieri’s The Grammar of Society. Our research differs from Bicchieri’s in our approach to experimentation: where she relies on lab experiments, we have constructed an experimental platform based on an internet survey instrument; where she relies on rational reconstructions, we do not. In this paper we focus on four contrasts in our methods: (1) we provide a space to explore ethical influence and norm (...)
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