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Clinical Trial Designs
Published in Gary L. Rosner, Purushottam W. Laud, Wesley O. Johnson, Bayesian Thinking in Biostatistics, 2021
Gary L. Rosner, Purushottam W. Laud, Wesley O. Johnson
A good summary of Bayesian adaptive designs as of 2011 is contained in Berry et al. [41]. A full presentation of adaptive randomization would include discussion of the ethical considerations, in addition to the statistical and logistic issues. The ethical considerations touch on the generally accepted need for clinical equipoise for participation in a randomized clinical trial. One may consider the views of Armitage and Bather, expressed in 1985, to get a sense of some of the early differences of opinion [10, 11, 19, 20] on the matter of adaptively modifying randomization probabilities in light of accruing information in the trial. Hey et al. (2015) argue against adaptively changing randomization probabilities on ethical grounds [163]. Many authors provide counterarguments in the discussion that followed that paper.
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Published in Filomena Pereira-Maxwell, Medical Statistics, 2018
From the website (http://www.equator-network.org; accessed 12/2016): “The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines. [...]” The organization’s website serves as a hub for well over 300 reporting guidelines, including CONSORT, PRISMA, STROBE, STARD, and TRIPOD. Equipoise Or more specifically, clinical equipoise. In the context of medical research, the lack of certainty regarding the comparative merits of alternative therapies for a given target disease among certain patient groups or populations (FREEDMAN, 1987). Sackett, in HAYNES et al. (eds., 2006), discusses equipoise and uncertainty, and points out the need to take the individual clinician’s and individual patient’s uncertainty into account, in addition to the more general uncertainty of the professional community. Clinical equipoise provides ethical justification (among other factors) for randomization in the conduct of clinical trials, and individual- level uncertainty provides justification for the enrollment of a particular patient into a clinical trial. SENN (2008) provides additional discussion. See also eligibility, exclusion criteria.
Proper Randomization Reduces the Chance of Wasted Biomedical Research
Published in Vance W. Berger, Randomization, Masking, and Allocation Concealment, 2017
The randomization process is important because it is based on clinical equipoise’s principle5 (Freedman 1987). According to this principle, “Clinical equipoise obtains when, for the population of patients from which subjects will be selected, the available clinical evidence does not favor one of the treatments being used over the others. In addition, it must be the case that there are no treatments available outside the trial that are better than those used in the trial. Satisfaction of these conditions seems to imply that the interests of research subjects will not be undermined in the service of collecting scientific information. If the available data do not favor any of the treatments being used, randomizing subjects seems as good a process as any other for choosing which treatment they receive” (Wendler 2016). As the intervention groups have equi poise, a judge will be required to elucidate what the best treatment is: randomization will be the judge. The opposite would be against ethics.
Live birth rate following undisturbed embryo culture at low oxygen in a time-lapse incubator compared to a high-quality benchtop incubator
Published in Human Fertility, 2022
Dimitrios Kalleas, Keith McEvoy, Gregory Horne, Stephen A. Roberts, Daniel R. Brison
There is limited evidence that TL culture systems support higher live birth rates compared to conventional embryo culture, however the interpretation of published studies is confounded by two main issues. First, many studies use TL for undisturbed embryo culture, but also use algorithms based on imaging for embryo selection. Thus, it is not clear which aspect(s) of TL is beneficial. Ideally, properly designed prospective randomized controlled trials (RCTs) are required to address this issue (Armstrong, Arroll, Cree, Jordan, & Farquhar, 2015; Armstrong et al., 2019), however there is a real question as to whether the required environment of clinical equipoise still exists to allow these to be undertaken. The second issue is that even for studies which compare solely the efficacy of the culture systems, ignoring TL selection algorithms, the control incubators against which new TL technology is compared are frequently inappropriate, being traditional “big box” incubators originally designed for tissue culture, using atmospheric oxygen levels. Some of these studies show no benefit of TL culture in terms of embryo grade or pregnancy and live birth outcomes, while the ones that do may reflect suboptimal control conditions (Alhelou, Mat Adenan, & Ali, 2018; Barrie et al., 2017; Cruz et al., 2011; Meseguer et al., 2011; Rubio et al., 2014). In the one published RCT, in ICSI cycles only, using a high-quality control incubator, there was no effect on clinical pregnancy and implantation rates (Barberet et al., 2018).
Is the concept of clinical equipoise maintained in psoriasis research?
Published in Journal of Dermatological Treatment, 2020
Catherine Nguyen, Anne Housholder, Alan Fleischer
Clinical equipoise is a concept that was first proposed as the ethical justification for the randomization of patients within a clinical trial. It is the belief that there is insufficient evidence to suggest that one arm within the trial is inferior to the others (3). Thus, if there is uncertainty or disagreement among the expert community about which arm of a trial is superior, the scientific and societal value of the study is maintained. Otherwise, the benefit to the general public is low compared to the human and material resources invested. Clinical equipoise can be applied to the ethical dilemma of placebo-controlled trials, in which patients in the placebo arm may be argued to receive substandard care (4). In placebo-controlled trials, equipoise would be obtained if there is no standard treatment for the condition, or if the evidence supporting a standard of treatment is in doubt. However, if an agreement among the expert medical community on a standard of care exists, patients within the placebo arm may be argued to receive diminished clinical care at the expense of the advancement of medical knowledge. Clinical equipoise would not maintain its validity and the ethical nature of the trial would be questioned.
Response to Open Peer Commentaries on “Misrepresenting ‘Usual Care’ in Research: An Ethical and Scientific Error”
Published in The American Journal of Bioethics, 2020
Ruth Macklin, Charles Natanson
Goldstein and Weijer (2020) contend that the chief problem in comparative effectiveness trials is not whether or not the interventions are usual care. Rather, they claim, it is the “misclassification of usual care interventions as clinical practice.” They argue that the main concern is the need for interventions to fulfill the ethical requirement of clinical equipoise. We agree with that requirement, but still maintain that the informed consent process is seriously flawed if it mistakenly identifies one or both arms of a trial as usual care. Accurate identification of the interventions in clinical trials is compatible with requiring clinical equipoise and may even aid in determining whether equipoise exists. For example, if researchers proposing a study that compares two current interventions conduct the requisite background inquiry to ascertain whether both interventions represent current practice (as we argue they should), they may find that one usual-care intervention carries more risks or has greater benefits than the other. In that case, equipoise may be uncertain, if not absent, and the question arises whether the proposed study should be carried out.