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.

Introduction: Conversion and the practice of transformation -- The philosophical structure of Jonathan Edwards's religious affections -- Habit, habit change, and conversion in C.S. Peirce -- Reconstructing faith : religious overcoming in Dewey's pragmatism -- Transforming obligation in William James -- Dwelling in absence: the reflective origin of conversion -- Creative transformation : the work of conversion -- The evasion of conversion in recent American philosophy.

This paperback edition is fully updated with new chapters on the livestoick crisis, fishing and BSE and a layman's guide introduction to philosophical concepts, ...

Philosopher Roger Scruton offers a wide-ranging perspective on philosophy, from logic to aesthetics, written in a lively and engaging way that is sure to stimulate debate. Rather than producing a survey of an academic discipline, Scruton reclaims philosophy for worldly concerns.

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

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.

Roger North's The Musicall Grammarian 1728 is a treatise on musical eloquence in all its branches. Of its five parts, I and II, on the orthoepy, orthography and syntax of music, constitute a grammar; III and IV, on the arts of invention and communication, form a rhetoric; and V, on etymology, consists of a history. Two substantial chapters of commentary introduce the text, which is edited here for the first time in its entirety: Jamie Kassler places his treatise within (...) the broader context not only of North's musical and non-musical writings but also their relation to the intellectual ferment of the seventeenth and eighteenth centuries and Mary Chan describes physical and textual aspects of the treatise as evidence for North's processes of thinking about musical thinking. (shrink)

This volume brings together much of the most influential work undertaken in the field of virtue ethics over the last four decades. The ethics of virtue predominated in the ancient world, and recent moral philosophy has seen a revival of interest in virtue ethics as a rival to Kantian and utilitarian approaches to morality. Divided into four sections, the collection includes articles critical of other traditions; early attempts to offer a positive vision of virtue ethics; some later criticisms of the (...) revival of virtue ethics; and, finally, some recent, more theoretically ambitious essays in virtue ethics. (shrink)

In this lucid and engaging introductory volume on the nature of society, Roger Trigg examines the scientific basis of social science and shows that philosophical presuppositions are a necessary starting point for the study of society.

This book is intended as an equivalent to or substitute for that "more reflective reading" which Rousseau considered essential to an understanding of his ideas. It is designed to complement perusal of the texts themselves, and the arrangement is such that chapters on each of Rousseau's major writings can be consulted separately or the commentary may be read through in sequence. The author's purpose is not to present a "key" to Rousseau's political philosophy, but rather to explore the works themselves (...) in an effort to reveal Rousseau's "system," from which the reader may then draw his own conclusions. Originally published in 1976. The Princeton Legacy Library uses the latest print-on-demand technology to again make available previously out-of-print books from the distinguished backlist of Princeton University Press. These editions preserve the original texts of these important books while presenting them in durable paperback and hardcover editions. The goal of the Princeton Legacy Library is to vastly increase access to the rich scholarly heritage found in the thousands of books published by Princeton University Press since its founding in 1905. (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)

This volume provides a philosophical introduction to and analysis of the study of metaphor. By proceeding from the concrete analysis of complex metaphors, White is able to identify a range of features which are incompatible with standard accounts of the way words function in metaphor.

_The Undiscovered Dewey_ explores the profound influence of evolution and its corresponding ideas of contingency and uncertainty on John Dewey's philosophy of action, particularly its argument that inquiry proceeds from the uncertainty of human activity. Dewey separated the meaningfulness of inquiry from a larger metaphysical story concerning the certainty of human progress. He then connected this thread to the way in which our reflective capacities aid us in improving our lives. Dewey therefore launched a new understanding of the modern self (...) that encouraged intervention in social and natural environments but which nonetheless demanded courage and humility because of the intimate relationship between action and uncertainty. Melvin L. Rogers explicitly connects Dewey's theory of inquiry to his religious, moral, and political philosophy. He argues that, contrary to common belief, Dewey sought a place for religious commitment within a democratic society sensitive to modern pluralism. Against those who regard Dewey as indifferent to moral conflict, Rogers points to Dewey's appreciation for the incommensurability of our ethical commitments. His deep respect for modern pluralism, argues Rogers, led Dewey to articulate a negotiation between experts and the public so that power did not lapse into domination. Exhibiting an abiding faith in the reflective and contestable character of inquiry, Dewey strongly engaged with the complexity of our religious, moral, and political lives. (shrink)

Brings together essays on the philosophy of art in which a philosophical theory of aesthetic judgment is tested and developed through its application to particular examples. Each essay approaches, from its own field of study, what Roger Scruton argues to be the central problems of aesthetics -- what is aesthetic experience, and what is its importance for human conduct? The book is divided into four parts. The first contains a resume of modern analytical aesthetics, which also serves as an (...) introduction to subsequent chapters. It also includes an essay that reviews current theories of literary criticism. The second part is devoted to musical aesthetics and contains the theoretical core of the work. Here Scruton describes the contours of aesthetic understanding, and defends the view that the object of aesthetic experience is inherently significant, even when it has no "content" that can be described in propositional terms. He rebuts the view that music is representational, and in the third part goes on to propose a theory of representation whereby to refute the suggestion that photography is a representational art. This third section also contains a study of film. The final part comprises essays relating aesthetic judgment to the understanding of culture, humor, and design. It covers many subjects, including the prose works of Samuel Beckett and the architecture of Leninism. The essays in this book form parts of a single intellectual enterprise, which is to give analytical foundations to the criticism of literature, visual art, music, and culture. (shrink)

This volume contains eighteen essays by established and younger historians that examine non-democratic alternative political systems and ideologies--oligarchies, monarchies, mixed constitutions--along with diverse forms of communal and regional associations such as ethnoi, amphiktyonies, and confederacies. The papers, which span the length and breadth of the Hellenic world highlight the immense political flexibility and diversity of ancient Greek civilization.

Aesthetics, hermeneutics, criticism -- Social Werktreue and the subjectivization of aesthetics -- From musike to metaphysics -- Formalist aesthetics and musical hermeneutics -- Deconstructing the disciplinary divide -- The question of metaphor -- Mimesis and the hermeneutics of music -- Political critique and the politics of music criticism -- Toward a hermeneutics of music criticism.

This paper argues for two theses: that degrees of belief are context sensitive; that outright belief is belief to degree 1. The latter thesis is rejected quickly in most discussions of the relationship between credence and belief, but the former thesis undermines the usual reasons for doing so. Furthermore, identifying belief with credence 1 allows nice solutions to a number of problems for the most widely-held view of the relationship between credence and belief, the threshold view. I provide a sketch (...) of a formal framework on which both theses are true. This is a modified Bayesian framework; I argue that despite making credences context-sensitive, the framework lets Bayesians hold on to their signature explanatory successes. The sort of context-sensitivity claimed for credences here mirrors the sort of context-sensitivity I have elsewhere claimed for outright belief: one's credences depend, in part, on the space of alternative possibilities one takes seriously in a context. (shrink)

In this article, I bring together the archive of institutional activism of Niara Sudarkasa in the U.S. and the posthumous impact of activist and public administrator Marielle Franco. The 1970s historical sources show Sudarkasa’s institutional solidarity with students and faculty in the creation of one of the first Africana Studies departments in the U.S. Reading them, I articulate an ethos for the curation ‘715 Haven Street: Art Looks Back,’ a public digital art gallery comprised of art and history found in (...) the DAAS Papers (Department of Afroamerican and African Studies) housed in the Bentley Library’s digital and physical archives. The analysis of the primary sources is guided by an engagement with the ‘Marielle Effect,’ generating a historical parameter for Abolitionist solidarity between American, Brazilian, Latin American, African American, Diasporic, and ally scholarly communities. The discussion of these parameters is embedded in my discussion of the concept of pacification, a phenomenon of colonial and post-colonial policing that survives through the perpetuation of an extra-judicial policing impetus articulated along race, identity, legality, and sexual legitimacy of subjects. (shrink)

Each title in the "Key Issues" series aims to set the work in its historical context. In this collection of contemporary responses to "Leviathan", attention is focused on its critics who attacked Hobbes's moral, political and religious ideas in a series of pamphlets and short books.

The earliest Analects yet discovered, this work provides us with a new perspective on the central canonical text that has defined Chinese culture--and clearly illuminates the spirit and values of Confucius.

Challenging commonly held biological, religious, and ethical beliefs, internationally well known historian of science Roger Smith boldly argues that human nature is not some "thing" awaiting discovery but is active in understanding itself. According to Smith, "being human" is a self-creation made possible through a reflective circle of thought and action, with a past and a future, and studying this "history" from a range of perspectives is fundamental to human self-understanding. Smith's argument brings together historical and contemporary debates concerning (...) materialism and human nature and the relations of the different fields of knowledge. He draws on classic writings from across the human sciences, touching on sociology, anthropology, brain sciences, history, philosophical hermeneutics, and critical theory, and demonstrates that there is no position outside history for an absolutely objective or eternally valid view of human nature. The question "what is human?" does not have and could not possible have one answer. Instead, there exists a variety of answers for different purposes, and there are good reasons for the many conceptions of what it is to be human. Smith does not treat human nature as only biological, economic, or moral, but as a multidimensional subject that should be considered in its proper historical context. By understanding this context, Smith believes, we can come to a truer understanding of ourselves. Persuasively and elegantly written, _Being Human_ takes an important new turn in the philosophical study of being human. (shrink)

In Reasons and the Good Roger Crisp answers some of the oldest questions in moral philosophy. Fundamental to ethics, he claims, is the idea of ultimate reasons for action; and he argues controversially that these reasons do not depend on moral concepts. He investigates the nature of reasons themselves, and how we come to know them. He defends a hedonistic theory of well-being and an account of practical reason according to which we can give some, though not overriding, priority (...) to our own good over that of others. (shrink)

" Montre-moi comment tu marches, je te dirai comment tu penses!... " II suffit de déambuler avec les philosophes en compagnie de Roger-Pol Droit — de la Grèce antique à nos jours, de Copenhague au Tibet —, pour comprendre à quel point marcher debout définit notre humanité. Et pour saisir comment marcher, parler et penser ne forment qu'un seul et même mouvement : être sur le point de tomber, se rattraper et recommencer sans fin. Aristote arpentant le gymmase du (...) Lycée avec ses disciples, Kant faisant sa promenade quotidienne dans Kônigsberg, Rousseau traversant la France à pied, Nietzsche cheminant sur les crêtes de Sils-Maria... chacun connaît ces silhouettes de philosophes en mouvement. Mais bien d'autres sont à découvrir qui, en changeant de continent ou de langue, ont élaboré leur pensée en marchant. En 27 récits allègres et virtuoses, Roger-Pol Droit dessine autour de la marche une petite histoire de la philosophie. Une randonnée littéraire inattendue et accessible à tous. (shrink)

W. V. Quine was quite simply the most distinguished analytic philosopher of the later half of the twentieth century. His celebrated attack on the analytic/synthetic tradition heralded a major shift away from the views of language descended from logical positivism. His most important book, Word and Object, introduced the concept of indeterminacy of radical translation, a bleak view of the nature of the language with which we ascribe thoughts and beliefs to ourselves and others. Quine is also famous for the (...) view that epistemology should be naturalized, that is conducted in a scientific spirit with the object of investigating the relationship between the inputs of experience and the outputs of belief. The eleven essays in this volume cover all the central topics of Quine's philosophy: the underdetermination of physical theory, analycity, naturalism, propositional attitudes, behaviorism, reference and ontology, positivism, holism and logic. (shrink)

Transactions and Encounters examines a diverse range of emerging technologies in the Victorian era. Such topics are explored as the popular craze for microscopes the uncanny possibilities of the telephone the jostling for authority between literature and science, with scenes by and including Dickens and Lewes, Huxley and Gosse the weird imaginary around androgynous barnacles and the competing versions of a mind-reading act. These essays combine to produce an invigorating and involving attempt to re-cast understandings of 19th century encounters between (...) the cultural and scientific spheres. (shrink)

This work presents an engaging interdisciplinary study of the nature and scope of interpretation, one of the most important areas of inquiry in today's ...