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 patient-relevant than any single outcome measure. (...) Critics, on the other hand, argue that the use of composites threatens the scientific objectivity of the trial by introducing new risks, and that in practice components are inconsistently defined, unreasonably combined, and inadequately reported. Philosophical scrutiny can help shed light in these disagreements and disentangle ethical and epistemological issues of composites in clinical trials. I examine common use of composites in cardiovascular trials, and show how composite results can be problematic, even misleading, if the proper range of scientific decisions and their consequences are ignored when judging the composite. Philosophies of science that are principled on normative versions of the argument from inductive risk can help explicate issues with composites. I conclude by suggesting ways of remedying composite issues in clinical trials. (shrink)

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 (...) what inference should be drawn from the data. "The dispute over stopping rule is far from being a marginal quibble, but is instead a striking illustration of the divergence of fundamental aims and standards separating Bayesians and advocates of orthodox statistical methods" (Steel 2004, 195) ... (shrink)

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 (...) computer simulations to show how the framework can assist in reconciling certain ethical conflicts. The framework is partial, lacking the precision of a complete systematization of statistical monitoring procedures in practice. (shrink)

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 (...) analog will lead us to a decision-theoretic analogy for much more systematic documentation of decisions in clinical trials. My conclusion is twofold: every DSMB decision should articulate a clear general principle (a ratio decidendi) that gives reason for the decision; and all such decisions should be made public. I use Bartha’s (2010) theory of analogical arguments to both frame and assess my argument by analogy. (shrink)

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 requiring multiple (...) interim analyses. The method of conditional power, together with a rationing principle for RCTs, can assist ES in addressing such issues. (shrink)

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 (...) set of criteria. The framework allows decision analysts to generate and quickly answer ‘what-if’ questions by simulating alternate trial scenarios. I illustrate the framework with a case study of an RCT that was stopped early due to harm. This was a trial of vitamin A supplement in relation to HIV transmission from mother-to-child through breastfeeding. (shrink)

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 (...) causal association. Cornfield's odds ratio in case‐control studies — as a good estimate of relative risk — together with his argument of ''explanatory common cause'' became important tools to use in confronting the skeptics. In this paper, I revisit this important historical episode as recorded in the Journal of National Cancer Institute and the Journal of the American Statistical Association. More specifically, I examine Cornfield's necessary condition on the minimum magnitudes of relative risk in light of confounders. This episode yields important insight into the nature of causal inference by showing the sorts of evidence appealed to by practitioners in supporting claims of causal association. I discuss this event in light of the manipulationist account of causation. (shrink)

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 both ethical and epistemic considerations. The framework is broadly Bayesian and addresses (...) a fundamental question behind many concerns about clinical trials: What does it take for an interim decision (e.g., whether to stop the trial, or continue) to be a good decision? I provide simulation illustrating the modeling of interim decisions counterfactually using the framework. (shrink)

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 ...

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 (...) that address the complexity of interpreting and responding to interim data, based on a broad range of epistemic and ethical factors. While they are not stopping rules, they would assist a Data Monitoring Committee in judging its position with regard to necessary precautionary interpretation of interim data. By vindicating a framework that accommodates a wide range of approaches to statistical inference in one important setting (clinical trials), my results pose a serious challenge for any approach that advocates a single, universal principle of statistical inference. (shrink)

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 (...) transmission between participants, belief and choice revision, and reputation over time; (2) we provide ways for participants to expand the context of their and others’ decisions; (3) we focus on more realistic ethical decisions than is allowed by games; and (4) we explain why Bicchieri’s method of rational reconstructions presents challenges to her theory of social norms. Our methods are complementary to Bicchieri’s, and together we can work toward developing more comprehensive empirically informed ethics. †To contact the authors, please write to Peter Danielson, W. Maurice Young Centre for Applied Ethics, University of British Columbia, 227‐6356 Agricultural Road, Vancouver, V6T 1Z2, Canada; e‐mail: [email protected]. (shrink)

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 to read Buchanan’s selected essays.

I argue that its appearing to you that P does not provide justification for believing that P unless you have independent justification for the denial of skeptical alternatives – hypotheses incompatible with P but such that if they were true, it would still appear to you that P. Thus I challenge the popular view of ‘dogmatism,’ according to which for some contents P, you need only lack reason to suspect that skeptical alternatives are true, in order for an experience as (...) of P to justify belief that P. I pursue three lines of objection to dogmatism, having to do with probabilistic reasoning, considerations of future or hypothetically available justification, and epistemic circularity. I briefly sketch a fall-back position which avoids the problems raised. (shrink)

Michael Bergmann claims that all versions of epistemic internalism face an irresolvable dilemma. We show that there are many plausible versions of internalism that falsify this claim. First, we demonstrate that there are versions of ‘‘weak awareness internalism’’ that, contra Bergmann, do not succumb to the ‘‘Subject’s Perspective Objection’’ horn of the dilemma. Second, we show that there are versions of ‘‘strong awareness internalism’’ that do not fall prey to the dilemma’s ‘‘vicious regress’’ horn. We note along the way that (...) these versions of internalism do not, in avoiding one horn of the dilemma, succumb to the dilemma’s other horn. The upshot is that internalists have many available strategies for avoiding dilemmatic defeat. (shrink)

Argues that the only way to understand the Confucian vision of the consummate moral life is to take the tradition on its own terms.

I believe that Tom is the proud father of a baby boy. Why do I think his child is a boy? A natural answer might be that I remember that his name is ‘Owen’ which is usually a boy’s name. Here I’ve given information that might be part of a causal explanation of my believing that Tom’s baby is a boy. I do have such a memory and it is largely what sustains my conviction. But I haven’t given you just (...) any causally relevant information, I’ve given my grounds for my belief. I’ve given reasons that might justify me in supposing that Tom’s baby is a boy. Less naturally, the question might be taken as a request for a broader causal explanation of my holding this belief. Appropriate answers might cite all manner of facts concerning the evolution of the human race, why I chose to pursue philosophy and hence came to know Tom, the mechanisms of email transmission, the firing of various neurons, the circumstances of concept formation as a result of which I’m able to grasp the thought that Tom’s baby is a boy, and so on. It is an interesting question what distinguishes the narrower set of answers that I first suggested. I won’t pursue that here. I assume you have a good enough sense of the distinction I’m drawing. We might call the narrower set of answers justifying reasons, the kind of reasons I might cite in justifying my belief. Answers of the first sort are clearly relevant to epistemological evaluation. In assessing whether you know p or are rational in believing it to the degree you do, I will naturally want to consider what reasons you have for your belief. In deliberating myself about whether to believe p, in seeking an answer to the question of whether p, I will naturally consider what reasons or grounds I have to suppose that p. But what I want to focus on here is how explanations of the broader sort bear on such questions as whether to believe p. From a third-person perspective we can ask, ‘In assessing the epistemic status of S’s belief that p, what is the relevance of causal information that lies outside of the realm of justifying reasons?’ From the first-person standpoint we can ask ‘In seeking to answer whether p, how should such causal information affect my deliberations?’ At first it might seem that such broader causal information could have little relevance if any. Like any belief my belief that p can be traced back to innumerable causes from far and wide.. (shrink)

This is a three-part exchange on the relationship between belief and credence. It begins with an opening essay by Roger Clarke that argues for the claim that the notion of credence generalizes the notion of belief. Julia Staffel argues in her reply that we need to distinguish between mental states and models representing them, and that this helps us explain what it could mean that belief is a special case of credence. Roger Clarke's final essay reflects on the (...) compatibility of the previously discussed views with dualist and monist interpretations of our mental states and our ways of modeling them. (shrink)

Descartes and the last Scholastics: objections and replies -- Descartes and the Scotists -- Ideas, before and after Descartes -- The Cartesian destiny of form and matter -- Descartes, Basso, and Toletus: three kinds of Corpuscularians -- Scholastics and the new astronomy on the substance of the heavens -- Descartes and the Jesuits of La Fleche: the Eucharist -- Condemnations of Cartesianism: the extension and unity of the universe -- Cartesians, Gassendists, and censorship -- The cogito in the seventeenth century.

Introduction -- The mathematical roots of the concept of analogy -- Aristotle : the uses of analogy -- Aristotle : analogy and language -- Thomas Aquinas -- Immanuel Kant -- Karl Barth -- Final reflections.

Can human beings be free and responsible if there is an all-powerful God? Anselm of Canterbury offers viable answers to questions which have plagued religious people for at least two thousand years. Katherin Rogers examines Anselm's reconciliation of human free will and divine omnipotence in the context of current philosophical debates.

Introduction -- Anselm's classical theism -- The Augustinian legacy -- The purpose, definition, and structure of free choice -- Alternative possibilities and primary agency -- The causes of sin and the intelligibility problem -- Creaturely freedom and God as Creator Omnium -- Grace and free will -- Foreknowledge, freedom, and eternity : part I, the problem and historical background -- Foreknowledge, freedom, and eternity : part II, Anselm's solution -- The freedom of God.

The preface paradox does not show that it can be rational to have inconsistent beliefs, because preface writers do not have inconsistent beliefs. I argue, first, that a fully satisfactory solution to the preface paradox would have it that the preface writer's beliefs are consistent. The case here is on basic intuitive grounds, not the consequence of a theory of rationality or of belief. Second, I point out that there is an independently motivated theory of belief – sensitivism – which (...) allows such a solution. I sketch a sensitivist account of the preface writer's doxastic state. (shrink)

Offers an in-depth exposition of the Confucian conception of persons as the starting point of Confucian ethics.

A substantial body of recent philosophy envisages a close, congenial relationship between blame and morality. It has been posited, assumed or argued, for instance, that blame is responsive to moral...

Starting from an examination of foundational issues, the book covers a range of topics, including animals, agency, enjoyment, the good life, contemplation, ...

Beyond geometry : Leibniz and the science of law -- The force of law : will -- Leibniz's systema iuris -- From the gesetzbuch to the landrecht : the ALR and the triumph of legality -- The rule of law : the Crown Prince lectures and the grounding of legality in order and security -- From reason to history : Savigny's system and the rise of social legal science -- The Bürgerliches Gesetzbuch (BGB) of 1900 : positive legal science and (...) the end of justice. (shrink)

Abstract Scientific advances have made the end of life into the primary concern of medicine. But medicine also postpones the end of life, often until the time when we no longer have the mental and physical capacity to deal with it. I argue that we need to develop Nietzsche's idea of timely death, in order to find a moral basis for health care at the end of life, and that the crucial factor is the cultivation of the virtues that would (...) enable us to live in another and more reckless way. We should look on the problem not from the first-person point of view, but from the perspective of the other, and ask ourselves what is most admirable in another person, in his or her attitude to death. The point of timely death is to make death into the completion of life, where life is understood as a moral rather than a biological idea. (shrink)

This chapter contains sections titled: Understanding and Reality Tradition and Interpretation Forms of Realism Works cited.

Gödel appears to have believed strongly that the human mind cannot be explained in terms of any kind of computational physics, but he remained cautious in formulating this belief as a rigorous consequence of his incompleteness theorems. In this chapter, I discuss a modification of standard Gödel-type logical arguments, these appearing to strengthen Gödel’s conclusions, and attempt to provide a persuasive case in support of his standpoint that the actions of the mind must transcend computation. It appears that Gödel did (...) not consider the possibility that the laws of physics might themselves involve noncomputational procedures; accordingly, he found himself driven to the conclusion that mentality must lie beyond the actions of the physical brain. My own arguments, on the other hand, are from the scientific standpoint that the mind is a product of the brain’s physical activity. Accordingly, there must be something in the physical actions of the world that itself transcends computation. We do not appear to find such noncomputational action in the known laws of physics, however, so we must seek it in currently undiscovered laws going beyond presently accepted physical theory. I argue that the only plausibly relevant gap in current understanding lies in a fundamental incompleteness in quantum theory, which reveals itself only with significant mass displacements between quantum states (“Schrödinger’s cats”). I contend that the need for new physics enters when gravitational effects just begin to play a role. In a scheme developed jointly with Stuart Hameroff, this has direct relevance within neuronal microtubules, and I describe this (still speculative) scheme in the following. (shrink)

My intention is to show that, starting from an empiricist philosophy of mind, it is possible to give a systematic account of aesthetic experience. I argue that empiricism involves a certain theory of meaning and truth; one problem is to show how this theory is compatible with the activity of aesthetic judgment. I investigate and reject two attempts to delimit the realm of the aesthetic: one in terms of the individuality of the aesthetic object, and the other in terms of (...) 'aesthetic properties'. I go on to argue that aesthetic descriptions must not be thought to ascribe properties to their objects, and I show how the suggestion that they are non-descriptive need not conflict with the empiricist view of meaning. The problem is then seen to lie with the analysis of the 'acceptance-conditions' of aesthetic descriptions. I counter certain idealist objections to this approach, and then present a theory of imagination, in terms of which the acceptance conditions of aesthetic judgments may be described. This theory attempts to explain how the element of thought in aesthetic appreciation may become inseparable from an experience of its object, and how the aesthetic emotions are both like and unlike their equivalents in life. The first part concludes with an analysis of the general conditions of aesthetic experience. I try to show that aesthetic experience can be described in terms of certain 'formal' properties, independently of its material object. In the second part I am concerned to show that this empiricist theory of aesthetics does not, like most empiricist theories, make nonsense of our appreciation of art. First, I attempt to show that 'understanding' art is not merely a cognitive process, but involves certain experiences that can be accounted for in terms of the previous theory. I then analyse the concepts of representation and expression, and in the course of this analysis I attempt to refute what I take to be the most serious rival analysis of our appreciation of art - the semantic theory. (shrink)

Archaeology's Visual Culture explores archaeology through the lens of visual culture theory. The insistent visuality of archaeology is a key stimulus for the imaginative and creative interpretation of our encounters with the past, acknowledging the multiplicity of meanings that cohere around artifacts, archaeological sites and museum displays. Archaeology's Visual Culture investigates the nature of this projection, revealing an embedded subjectivity in the imagery of archaeology. Using a wide range of case studies the book highlights the way archaeologists view objects and (...) the consequences that ensue from ways of seeing"--Provided by publisher. (shrink)

Sexual experimentation, living together, raising children outside of marriage, remarriage after divorce, and same-sex relationships...These behaviours have become common in the wider society as well as among Christians and Catholic Christians. Not only do they think and act differently than the official Church teaching, but they do so convinced that they are acting rightly. This challenges ethics to respond by what can be called an 'ethics of mercy', by meeting people where they are and helping them to grow towards the (...) fullness of life and love. Such a pastoral and educational ethics of growth should dare to stand within the tension between what is desirable and what is attainable, without surrendering the 'pro-vocative' idea of conjugal covenant as the basis for the family. Mercy is needed not only after ethics but in ethics. In harmony with Pope Francis's plea for a 'gospel of mercy', this book seeks a middle way between merciless rigourism and relativising subjectivism. It proposes an ethics of redemption that accompanies people on their way to meaningful living and loving, grounded in a spirituality that springs from the salvation offered in Jesus. (shrink)

Uses a comparative hermeneutical method to explain the most important terms in the classical Confucian philosophical texts, in an effort to allow the tradition to speak on its own terms.

A-t-on le droit de croire en l'existence de Dieu? Non, répondent ceux qui veulent des preuves. Oui, affirme ce livre, car nous avons le droit de croire même sans justification épistémologique. Cela n'a rien d'intellectuellement honteux, contrairement à ce que disent certains philosophes, en parlant d'une éthique des croyances Une nouvelle question se pose alors : a-t-on le droit de croire avoir reçu une révélation et prétendre connaître ainsi la vérité? Non, répondent ceux pour lesquels la vérité ne peut pas (...) être donnée par Dieu dans la Bible. Oui, affirme ce livre, et, qui plus est, une épistémologie peut défendre la rationalité de notre croyance à la révélation. Dès lors, peut-on faire comme si les affirmations du Credo étaient des fictions? Est-il vrai que la religion est avant tout une affaire pratique et une forme de vie? Non, répond ce livre : les arguments en faveur d'une conception non réaliste de la religion sont faibles ; en revanche, le réalisme théologique peut être défendu. Renouvelant ainsi la traditionnelle question de la relation entre foi et raison, ce livre discute aussi bien les thèses de saint Thomas, de John Locke, du cardinal Newman et de Ludwig Wittgenstein, que celles de philosophes analytiques contemporains de la religion comme Alvin Plantinga, Richard Swinburne, Peter van Inwagen ou Linda Zagzebski. (shrink)

In addition the book also includes a good number of unpublished essays.

Winner of the Wolf Prize for his contribution to our understanding of the universe, Penrose takes on the question of whether artificial intelligence will ever ...