•  730
    Data and Safety Monitoring Board and the Ratio Decidendi of the Trial
    Journal of Philosophy, Science and Law 15 1-26. 2015.
    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 …Read more
  •  111
    Statistical decisions and the interim analyses of clinical trials
    Theoretical Medicine and Bioethics 32 (1): 61-74. 2011.
    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 mo…Read more
  •  93
    Error statistics 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 : ES provides limited guidance in cases of early unfavorable trends due to the possibility of trend reversal; ES is silent on how to prospectively control error rates in experiments r…Read more
  •  88
    Justice and Health Care: Selected Essays (review)
    Theoretical Medicine and Bioethics 32 (2): 137-142. 2011.
    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, there could hardly be a more appropriate time t…Read more
  •  80
    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 cli…Read more
  •  72
    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,…Read more
  •  70
    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 acco…Read more
  •  47
    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 ...
  •  41
    Nerd and norms: Framework and experiments
    with Peter Danielson and Alex Mesoudi
    Philosophy of Science 75 (5): 830-842. 2008.
    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 ethica…Read more
  •  37
    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. 2012.
    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 sto…Read more
  • This article presents a quantitative way of modeling the interim decisions of clinical trials. While statistical approaches tend to focus on the epistemic aspects of statistical monitoring rules, often overlooking ethical considerations, ethical approaches tend to neglect key epistemic dimension. The proposal is a second-order decision theoretic framework. The framework provides means for retrospective assessment of interim decisions based on a clear and consistent set of criteria that combines …Read more
  • The use of composite outcomes is becoming widespread in clinical trials. By combining individual outcome measures into a composite, researchers claim a composite can increase statistical precision and trial efficiency, expediting the trial by reducing sample size and cost, and consequently enabling researchers to answer questions that could not otherwise be answered. Another rationale given for using a composite is that it provides a measure of the net effect of the intervention that is more pat…Read more