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Franklin G. Miller - One of the best experts on this subject based on the ideXlab platform.
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is the concept of Clinical Equipoise still relevant to research
BMJ, 2017Co-Authors: Spencer Phillips Hey, Charles Weijer, Alex John London, Annette Rid, Franklin G. MillerAbstract:Spencer Hey, Alex John London, and Charles Weijer argue that there is no better framework for justifying patient participation in research. But Annette Rid and Franklin Miller say that it is a mistake to require Clinical research ethics to align with the norms of Clinical practice
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Clinical Equipoise and risk benefit assessment
Clinical Trials, 2012Co-Authors: Franklin G. MillerAbstract:Clinical Equipoise is widely regarded as an ethical requirement for the design and conduct of randomized controlled trials (RCTs). Underlying Clinical Equipoise is the norm that no patient should be randomized to treatment known (or believed by the expert Clinical community) to be inferior to the established standard of care. This implies that patient-subjects should not be exposed to net risks in control groups of randomized trials - risks that are not compensated by the prospect of direct medical benefits from the control intervention. However, proponents of Clinical Equipoise have no moral objections to permitting net risks for 'nontherapeutic' research procedures employed in Clinical trials. This differential assessment makes risk-benefit assessment of randomized trials incoherent. In this article, I examine critically four arguments in defense of Clinical Equipoise as a requirement for risk-benefit assessment. Each of these arguments fails to support Clinical Equipoise, leading to the conclusion that we should dispense with this principle in risk-benefit assessment of RCTs.
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Equipoise asking the right questions for Clinical trial design
Nature Reviews Clinical Oncology, 2012Co-Authors: Steven Joffe, Franklin G. MillerAbstract:Randomized controlled trials (RCTs) are central to evidence-based Clinical and health-policy decisions. However, RCTs highlight the tension between the therapeutic obligations of the physician and the scientific obligations of the investigator. Clinical Equipoise, defined as honest professional disagreement among expert clinicians about the preferred treatment, is often cited as the solution to this RCT dilemma. Nevertheless, there are numerous practical and conceptual problems with the notion of Equipoise. These problems include its mistaken imposition of therapeutic norms on the scientific enterprise of research, the difficulty of knowing when a state of Equipoise exists, the susceptibility of expert judgment to bias and weak evidence, and its inability to support evidence necessary for health-policy decisions. An alternate approach to risk-benefit assessment that is congruent with the scientific purpose of RCTs can better guide ethical evaluation of these trials, as discussed in this Perspective.
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Equipoise and the dilemma of randomized Clinical trials
The New England Journal of Medicine, 2011Co-Authors: Franklin G. Miller, Steven JoffeAbstract:Clinical Equipoise, or uncertainty about which treatment is best for a patient, is widely viewed as essential for an ethical RCT. The authors argue that Clinical trials that violate Equipoise are e...
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Equipoise and the dilemma of randomized Clinical trials
The New England Journal of Medicine, 2011Co-Authors: Franklin G. Miller, Steven JoffeAbstract:Clinical Equipoise, or uncertainty about which treatment is best for a patient, is widely viewed as essential for an ethical RCT. The authors argue that Clinical trials that violate Equipoise are ethical and necessary to inform societal decisions about drug approval and coverage.
Howard Brody - One of the best experts on this subject based on the ideXlab platform.
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Clinical Equipoise and the incoherence of research ethics
Journal of Medicine and Philosophy, 2007Co-Authors: Franklin G. Miller, Howard BrodyAbstract:The doctrine of Clinical Equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomize...
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a critique of Clinical Equipoise therapeutic misconception in the ethics of Clinical trials
Hastings Center Report, 2003Co-Authors: Franklin G. Miller, Howard BrodyAbstract:: A predominant ethical view holds that physician-investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second-rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical Equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and Clinical Equipoise should be abandoned.
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therapeutic misconception in the ethics of Clinical trials a critique of Clinical Equipoise
Hastings Center Report, 2003Co-Authors: Franklin G. Miller, Howard BrodyAbstract:The Hypericum Depression Trial Study Group published in 2002 the results of a randomized trial comparing hypericum (St. John's Wort), sertraline (Zoloft), and placebo in the treatment of major depression. (1) In the study, funded by the National Institutes of Health, 340 subjects from twelve participating centers were randomized to three trial arms for an eight-week period, with careful monitoring to assure that patients who worsened significantly or who became suicidal were removed from the study and received adequate treatment. Neither hypericum nor sertraline was found to be superior to placebo on the primary outcome measures. The authors noted, "From a methodological point of view, this study can be considered an example of the importance of including inactive and active comparators in trials testing the possible antidepressant effects of medications. In fact, without a placebo, hypericum could easily have been considered as effective as sertraline." (2) What can we conclude about the ethics of this trial? One dominant viewpoint in research ethics would have prohibited the study. On this viewpoint, a randomized trial is ethical only in circumstances of "Clinical Equipoise"--a genuine uncertainty within the medical community as to whether (in this case) any of the three treatment arms are superior to the other two. No such uncertainty exists. Approximately twenty-five Clinically available antidepressants, including sertraline, have been shown to be superior to placebo. (3) Moreover, the majority opinion within psychiatry probably holds that sertraline is definitely superior to hypericum for major depression, even if hypericum has potential for the treatment of mild to moderate depression. But another widespread viewpoint would hold that the trial was ethically sound. Depressed individuals widely use hypericum, a "natural" agent, despite the lack of proven efficacy. Accordingly, a rigorous evaluation offered scientific, Clinical, and social value. According to the report of trial results, the study was approved by institutional review boards (IRBs) at twelve sites and subjects provided written informed consent. But if Clinical Equipoise is a basic requirement for ethical research, how could all these review boards be blind to the unethical nature of this trial? And how could two such radically divergent viewpoints exist, without research ethics being widely regarded as in a state of crisis? Therapeutic Misconceptions The prevailing ethical perspective on Clinical trials holds that physician-investigators can discharge their "therapeutic obligation" to patients in the context of randomized Clinical trials (RCTs) as long as treatments being tested scientifically satisfy Clinical Equipoise. We contend that this ethical perspective is fundamentally flawed. An ethical framework that provides normative guidance about a practice should accurately characterize the practice. The prevailing ethical perspective fails this test: All sound ethical thinking about Clinical research, and the regulatory framework for review of protocols for Clinical investigation, depends on a basic distinction between research and therapy. But the claims in the prevailing ethical perspective on Clinical trials conflate research and therapy. These claims are that the ethics of the physician-patient relationship must govern RCTs, that physicians who conduct these trials have a "therapeutic obligation" to patients enrolled in them, and that RCTs must be compatible with some form of Equipoise. Certainly, investigators and ethicists recognize that Clinical trials are scientific experiments, which differ from standard medical care. They also recognize that they are subject to regulatory requirements which do not apply to routine medical practice. However, the prevailing ethical framework views Clinical trials through a therapeutic lens. The mainstream ethical approach to Clinical trials attempts to have it both ways: to view the Clinical trial as a scientific experiment, aimed at producing knowledge that can help improve the care of future patients, and as treatment conducted by physicians who retain fidelity to the principles of therapeutic beneficence and therapeutic non-maleficence that govern the ethics of Clinical medicine. …
Steven Joffe - One of the best experts on this subject based on the ideXlab platform.
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Equipoise asking the right questions for Clinical trial design
Nature Reviews Clinical Oncology, 2012Co-Authors: Steven Joffe, Franklin G. MillerAbstract:Randomized controlled trials (RCTs) are central to evidence-based Clinical and health-policy decisions. However, RCTs highlight the tension between the therapeutic obligations of the physician and the scientific obligations of the investigator. Clinical Equipoise, defined as honest professional disagreement among expert clinicians about the preferred treatment, is often cited as the solution to this RCT dilemma. Nevertheless, there are numerous practical and conceptual problems with the notion of Equipoise. These problems include its mistaken imposition of therapeutic norms on the scientific enterprise of research, the difficulty of knowing when a state of Equipoise exists, the susceptibility of expert judgment to bias and weak evidence, and its inability to support evidence necessary for health-policy decisions. An alternate approach to risk-benefit assessment that is congruent with the scientific purpose of RCTs can better guide ethical evaluation of these trials, as discussed in this Perspective.
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Equipoise and the dilemma of randomized Clinical trials
The New England Journal of Medicine, 2011Co-Authors: Franklin G. Miller, Steven JoffeAbstract:Clinical Equipoise, or uncertainty about which treatment is best for a patient, is widely viewed as essential for an ethical RCT. The authors argue that Clinical trials that violate Equipoise are e...
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Equipoise and the dilemma of randomized Clinical trials
The New England Journal of Medicine, 2011Co-Authors: Franklin G. Miller, Steven JoffeAbstract:Clinical Equipoise, or uncertainty about which treatment is best for a patient, is widely viewed as essential for an ethical RCT. The authors argue that Clinical trials that violate Equipoise are ethical and necessary to inform societal decisions about drug approval and coverage.
Charles Weijer - One of the best experts on this subject based on the ideXlab platform.
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is the concept of Clinical Equipoise still relevant to research
BMJ, 2017Co-Authors: Spencer Phillips Hey, Charles Weijer, Alex John London, Annette Rid, Franklin G. MillerAbstract:Spencer Hey, Alex John London, and Charles Weijer argue that there is no better framework for justifying patient participation in research. But Annette Rid and Franklin Miller say that it is a mistake to require Clinical research ethics to align with the norms of Clinical practice
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does Clinical Equipoise apply to cluster randomized trials in health research
Trials, 2011Co-Authors: Ariella Binik, Charles Weijer, Andrew D Mcrae, Jeremy M Grimshaw, Robert F Boruch, Jamie C Brehaut, Allan DonnerAbstract:This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does Clinical Equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of Clinical Equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of Clinical Equipoise to CRTs is uncertain. Here we argue that Clinical Equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, Clinical Equipoise is applicable to CRTs. Clinical Equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, Clinical Equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial. Finally, Clinical Equipoise provides research ethics committees with formal and procedural guidelines that form an important part of the assessment of the benefits and harms of CRTs in health research.
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Equipoise and the duty of care in Clinical research a philosophical response to our critics
Journal of Medicine and Philosophy, 2007Co-Authors: Paul B Miller, Charles WeijerAbstract:Franklin G. Miller and colleagues have stimulated renewed interest in research ethics through their work criticizing Clinical Equipoise. Over three years and some twenty articles, they have also worked to articulate a positive alternative view on norms governing the conduct of Clinical research. Shared presuppositions underlie the positive and critical dimensions of Miller and colleagues' work. However, recognizing that constructive contributions to the field ought to enjoy priority, we presently scrutinize the constructive dimension of their work. We argue that it is wanting in several respects.
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Clinical Equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial
BMJ, 2000Co-Authors: Charles Weijer, Stanley H Shapiro, Kathleen Cranley GlassAbstract:# Clinical Equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial {#article-title-2} The ethical basis for entering patients in randomised controlled trials is under debate. Some doctors espouse the uncertainty principle whereby randomisation to treatment is acceptable when an individual doctor is genuinely unsure which treatment is best for a patient. Others believe that Clinical Equipoise, reflecting collective professional uncertainty over treatment, is the soundest ethical criterion. Here doctors from two Canadian centres discuss their positions. # For {#article-title-3} On what ethical grounds may a physician offer trial participation to his or her patient? The answer seems to depend greatly on which side of the Atlantic you reside. In the United Kingdom, the uncertainty principle is widely endorsed. 1 2 However, in North America, Clinical Equipoise—reflecting collective uncertainty—is the dominant ethical basis.3 Which of these principles offers the preferred moral underpinning for the randomised controlled trial? It is widely acknowledged that physicians have a primary duty to promote their patients' welfare. When physicians become investigators, however, other ends such as recruiting enough subjects and retaining them in the trial may conflict with this duty.4 How can the physician maintain fidelity to the patient and further the ends of a randomised controlled trial? The uncertainty principle offers an appealing solution to this problem. Physicians who are convinced that one treatment is better than another for a particular patient cannot ethically choose at random which treatment to give, they must do what they think best for the patient. For this reason, physicians who feel they already know the answer cannot enter their patients into a trial. If they think, whether for a wise or silly reason, that they know the answer before the trial starts, they should not enter any patients.2 On the other hand, if the physician is uncertain about which treatment is best for a patient, offering the patient randomisation to equally …
Fred Gifford - One of the best experts on this subject based on the ideXlab platform.
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pulling the plug on Clinical Equipoise a critique of miller and weijer
Kennedy Institute of Ethics Journal, 2007Co-Authors: Fred GiffordAbstract:As clinicians, researchers, bioethicists, and members of society, we face a number of moral dilemmas concerning randomized Clinical trials. How we manage the starting and stopping of such trials--how we conceptualize what evidence is sufficient for these decisions--has implications for both our obligations to trial participants and for the nature and security of the resultant medical knowledge. One view of how this is to be done, "Clinical Equipoise," recently has been given an extended defense by Paul Miller and Charles Weijer in their article "Rehabilitating Equipoise." The present paper critiques this position and Miller and Weijer's defense of it. I argue that their attempted rehabilitation fails. Their analysis suffers from a number of confusions, as well as a failure to make crucial distinctions, adequately to clarify key concepts, or to think through exactly what needs to be established to justify their claim. We are left with little reason to uphold the Clinical Equipoise criterion.
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so called Clinical Equipoise and the argument from design
Journal of Medicine and Philosophy, 2007Co-Authors: Fred GiffordAbstract:In this article, I review and expand upon arguments showing that Freedman's so-called "Clinical Equipoise" criterion cannot serve as an appropriate guide and justification for the moral legitimacy of carrying out randomized Clinical trials. At the same time, I try to explain why this approach has been given so much credence despite compelling arguments against it, including the fact that Freedman's original discussion framed the issues in a misleading way, making certain things invisible: Clinical Equipoise is conflated with community Equipoise, and several versions of each are also conflated. But a misleading impression is given that, rather than distinct criteria being arbitrarily conflated, a puzzle is solved and a number of features unified. Various issues are pushed under the rug, hiding flaws of the "Clinical Equipoise" approach and thus deceiving us into thinking that we have a solution when we do not. Particularly significant is the ignoring of the crucial distinction between the individual patient decision and the policy decision.
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uncertainty about Clinical Equipoise Clinical Equipoise and the uncertainty principles both require further scrutiny
BMJ, 2001Co-Authors: Fred GiffordAbstract:Editor—The exchange between Weijer et al and Enkin addresses the question of under what circumstances and for what reasons entering patients in Clinical trials can be morally justified.1 It is important to see, however, that the issues are a good deal more complicated. There are problems on both sides, but I will focus on Clinical Equipoise.
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freedman s Clinical Equipoise and sliding scale all dimensions considered Equipoise
Journal of Medicine and Philosophy, 2000Co-Authors: Fred GiffordAbstract:It is often claimed that a Clinical investigator may ethically participate (e.g., enroll patients) in a trial only if she is in Equipoise (if she has no way to ground a preference for one arm of the study). But this is a serious problem, for as data accumulate, it can be expected that there will be a discernible trend favoring one of the treatments prior to the point where we achieve the trial's objective. In this paper, I critically evaluate Benjamin Freedman's 'Clinical Equipoise' solution to this dilemma. I argue that Freedman actually puts forth at least two distinct contrasts - one in terms of community vs. individual Equipoise, and another concerning Clinical vs. theoretical Equipoise - and that neither of them resolves the dilemma. I then make a proposal for a more adequate account of how to think about the circumstances under which entering subjects in trials would be justified - a 'sliding-scale Equipoise' that arises out of a discussion of patients' values.