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Spencer Hey
Harvard University
  1.  62
    Heuristics and Meta-Heuristics in Scientific Judgement.Spencer Phillips Hey - 2016 - British Journal for the Philosophy of Science 67 (2):471-495.
    Despite the increasing recognition that heuristics may be involved in myriad scientific activities, much about how to use them prudently remains obscure. As typically defined, heuristics are efficient rules or procedures for converting complex problems into simpler ones. But this increased efficiency and problem-solving power comes at the cost of a systematic bias. As Wimsatt showed, biased modelling heuristics can conceal errors, leading to poor decisions or inaccurate models. This liability to produce errors presents a fundamental challenge to the philosophical (...)
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  2.  18
    Challenges and Opportunities for Biomarker Validation.Spencer Phillips Hey, Elvira D'Andrea, Emily H. Jung, Frazer Tessema, Jing Luo, Bishal Gyawali & Aaron S. Kesselheim - 2019 - Journal of Law, Medicine and Ethics 47 (3):357-361.
    Biomarkers can be powerful tools to guide diagnosis, treatment, and research. However, prudent use of biomarkers requires formal validation efforts. Although the data needed for biomarker validation has traditionally been hard to access, new research initiatives can ease this process.
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  3.  53
    Robust and Discordant Evidence: Methodological Lessons From Clinical Research.Spencer Phillips Hey - 2015 - Philosophy of Science 82 (1):55-75.
    The concordance of results that are “robust” across multiple scientific modalities is widely considered to play a critical role in the epistemology of science. But what should we make of those cases where such multimodal evidence is discordant? Jacob Stegenga has recently argued that robustness is “worse than useless” in these cases, suggesting that “different kinds of evidence cannot be combined in a coherent way.” In this article I respond to this critique and illustrate the critical methodological role that robustness (...)
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  4. A Framework for Assessing Scientific Merit in Ethical Review of Clinical Research.Ariella Binik & Spencer Phillips Hey - 2019 - Ethics and Human Research 41 (2):2-13.
    Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that new decision-making tools are needed to help (...)
     
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  5.  91
    What Theories Are Tested in Clinical Trials?Spencer Phillips Hey - 2015 - Philosophy of Science 82 (5):1318-1329.
    John Worrall and Nancy Cartwright have both argued that randomized controlled trials are “testing the wrong theory.” They claim that RCTs are designed to test inferences about the causal relationships in the study population, but this does not guarantee a justified inference about the causal relationships in the more diverse population in clinical practice. In this article I argue that the epistemology of theory testing in trials is more complicated than either Worrall’s or Cartwright’s accounts suggest. I illustrate this more (...)
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  6.  47
    Assay Sensitivity and the Epistemic Contexts of Clinical Trials.Spencer Phillips Hey & Charles Weijer - 2013 - Perspectives in Biology and Medicine 56 (1):1-17.
    In February 2010, the World Medical Association hosted an international symposium on the ethics of placebo controls in clinical trials (WMA 2010). Despite years of debate, ethicists, clinical trialists, and policy makers remain divided over the ethical acceptability of using placebos in research when a proven, effective treatment is available. The protracted nature of this problem is due, at least in part, to a perceived conflict between the opposing demands placed on clinical research by science and ethics. A good, scientifically (...)
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  7.  28
    Do We Know Whether Researchers and Reviewers Are Estimating Risk and Benefit Accurately?Spencer Phillips Hey & Jonathan Kimmelman - 2016 - Bioethics 30 (8):609-617.
    Accurate estimation of risk and benefit is integral to good clinical research planning, ethical review, and study implementation. Some commentators have argued that various actors in clinical research systems are prone to biased or arbitrary risk/benefit estimation. In this commentary, we suggest the evidence supporting such claims is very limited. Most prior work has imputed risk/benefit beliefs based on past behavior or goals, rather than directly measuring them. We describe an approach – forecast analysis – that would enable direct and (...)
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  8.  15
    Why High Drug Pricing Is A Problem for Research Ethics.Spencer Phillips Hey - 2020 - Journal of Bioethical Inquiry 17 (1):29-35.
    The high price of drugs is receiving due consideration from ethicists, policymakers, and legislators. However, much of this attention has focused on the difference between the cost of drug development and company profits and the possible laws and regulations that could limit a drug’s price once it reaches market. By contrast, little attention has been paid to the ethical implications of high drug prices for the research subjects whose bodies were essential to the drug’s development. Indeed, the future price of (...)
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  9.  31
    The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials.Spencer Phillips Hey & Jonathan Kimmelman - 2014 - Kennedy Institute of Ethics Journal 24 (2):121-139.
    Should first-in-human trials be designed to maximize the prospect of therapeutic benefit for volunteers, prioritize avoidance of unintended harms, or aim for some happy medium between the two? Perennial controversies surrounding initiation and design of early-phase trials hinge on how this question is resolved. In this paper, we build on the premise that the task of early-phase testing is to optimize various components of a potential therapy so that later, confirmatory trials have the maximal probability of informing drug development and (...)
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  10. Judging Quality and Coordination in Biomarker Diagnostic Development.Spencer Phillips Hey - 2015 - Theoria: Revista de Teoría, Historia y Fundamentos de la Ciencia 30 (2):207-227.
    What makes a high-quality biomarker experiment? The success of personalized medicine hinges on the answer to this question. In this paper, I argue that judgment about the quality of biomarker experiments is mediated by the problem of theoretical underdetermination. That is, the network of biological and pathophysiological theories motivating a biomarker experiment is sufficiently complicated that it often frustrates valid interpretation of the experimental results. Drawing on a case-study in biomarker diagnostic development from neurooncology, I argue that this problem of (...)
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  11.  35
    Ethics and Epistemology of Accurate Prediction in Clinical Research.Spencer Phillips Hey - 2015 - Journal of Medical Ethics 41 (7):559-562.
    All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with (...)
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  12.  8
    What Questions Can a Placebo Answer?Spencer Phillips Hey & Charles Weijer - 2016 - Monash Bioethics Review 34 (1):23-36.
    The concept of clinical equipoise restricts the use of placebo controls in clinical trials when there already exists a proven effective treatment. Several critics of clinical equipoise have put forward alleged counter-examples to this restriction—describing instances of ethical placebo-controlled trials that apparently violate clinical equipoise. In this essay, we respond to these examples and show that clinical equipoise is not as restrictive of placebos as these authors assume. We argue that a subtler appreciation for clinical equipoise—in particular the distinction between (...)
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  13.  4
    Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence.Spencer Phillips Hey, William B. Feldman, Emily H. Jung, Elvira D'Andrea & Aaron S. Kesselheim - 2019 - Journal of Law, Medicine and Ethics 47 (3):381-387.
    The FDA's new table of surrogate endpoints used for drug approvals is an important step forward for overseeing the use of biomarkers in clinical trials. Nevertheless, we present several ways in which the table can be improved.
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  14.  42
    Epistemology, Ethics, and Progress in Precision Medicine.Spencer Phillips Hey & Brianna Barsanti-Innes - 2016 - Perspectives in Biology and Medicine 59 (3):293-310.
    One of the central goals of precision medicine is to dissolve the long-standing tension between the population-level data provided by traditional randomized controlled trials and the physician’s need to prescribe therapies for their individual patient. The RCT can tell the physician that therapy A is, on average, more effective than therapy B for a population of patients, P, but this does not tell her whether A is more effective for the particular patient, p1, in front of her. However, by leveraging (...)
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  15.  15
    Priority, Prediction and the Ethical Research Enterprise.Spencer Phillips Hey - 2017 - Journal of Medical Ethics 43 (12):812-813.
    In their essay, ‘When Clinical Trials Compete: Prioritizing Study Recruitment’, Gelinas et al describe a collective action problem that can arise if multiple trials at a single institution are all trying to recruit participants from the same patient population. Each trial may be addressing an important question, and each will need a certain number of participants to provide an informative answer. But because these trials are all recruiting from the same population, it is possible that there will not be enough (...)
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  16.  17
    Reprioritizing Research Activity for the Post‐Antibiotic Era: Ethical, Legal, and Social Considerations.Spencer Phillips Hey & Aaron S. Kesselheim - 2017 - Hastings Center Report 47 (2):16-20.
    Many hold that the so-called golden era of antibiotic discovery has passed, leaving only a limited clinical pipeline for new antibiotics. A logical conclusion of such arguments is that we need to reform the current system of antibiotic drug research—including clinical trials and regulatory requirements—to spur activity in discovery and development. The United States Congress in the past few years has debated a number of bills to address this crisis, including the 2012 Generating Antibiotic Incentives Now Act and the 2016 (...)
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  17.  35
    Stakeholder Views Regarding Ethical Issues in the Design and Conduct of Pragmatic Trials: Study Protocol.Stuart G. Nicholls, Kelly Carroll, Jamie Brehaut, Charles Weijer, Spencer Phillips Hey, Cory E. Goldstein, Merrick Zwarenstein, Ian D. Graham, Joanne E. McKenzie, Lauralyn McIntyre, Vipul Jairath, Marion K. Campbell, Jeremy M. Grimshaw, Dean A. Fergusson & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):90.
    Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...)
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  18.  11
    Defining “True and Non-Misleading” for Pharmaceutical Promotion.Spencer Phillips Hey & Aaron S. Kesselheim - 2018 - Journal of Law, Medicine and Ethics 46 (2):552-554.
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  19.  8
    Thinking Clearly About the FIRST Trial: Addressing Ethical Challenges in Cluster Randomised Trials of Policy Interventions Involving Health Providers.Austin R. Horn, Charles Weijer, Spencer Phillips Hey, Jamie Brehaut, Dean A. Fergusson, Cory E. Goldstein, Jeremy Grimshaw & Monica Taljaard - 2018 - Journal of Medical Ethics 44 (9):593-598.
    The ethics of the Flexibility In duty hour Requirements for Surgical Trainees trial have been vehemently debated. Views on the ethics of the FIRST trial range from it being completely unethical to wholly unproblematic. The FIRST trial illustrates the complex ethical challenges posed by cluster randomised trials of policy interventions involving healthcare professionals. In what follows, we have three objectives. First, we critically review the FIRST trial controversy, finding that commentators have failed to sufficiently identify and address many of the (...)
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  20.  7
    Complex Underdetermination and the Units of Clinical Translation.Spencer Phillips Hey - 2015 - Theoria 30 (2):207-227.
    What makes a high-quality biomarker experiment? The success of personalized medicine hinges on the answer to this question. Unfortunately, as many commentators have now emphasized, the quality of most biomarker experiments to date has been quite low. Although the technical side of this problem has received considerable attention, the philosophical issues remain largely unexplored. In this paper, I argue that understanding what constitutes a high-quality biomarker experiment requires some fundamental shifts in how we think about the epistemology, ontology, and methodology (...)
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  21.  3
    Heuristics and Explanation in Translational Medicine.Spencer Phillips Hey - 2019 - Perspectives in Biology and Medicine 62 (4):675-689.
    The reigning paradigm of rational drug discovery in translational medicine attempts to exploit biological theories and pathophysiological explanations to identify novel drug targets and therapeutic strategies. Given that there are limited human and material resources available for testing experimental therapeutics, this theory- and explanation-driven strategy of drug development seems to make good sense: it narrows the number of plausible drug candidates to be put through rigorous and expensive testing; it potentially improves the success rate of clinical translation; and it provides (...)
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