Results for 'Clinical trials'

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  1.  14
    Clinical Trial Application in Europe: What Will Change with the New Regulation?Viviana Giannuzzi, Annagrazia Altavilla, Lucia Ruggieri & Adriana Ceci - 2016 - Science and Engineering Ethics 22 (2):451-466.
    The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout (...)
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  2.  39
    Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.Liza Dawson & Sheryl Zwerski - 2015 - Bioethics 29 (5):316-323.
    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but (...)
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  3.  12
    When clinical trials compete: prioritising study recruitment.Luke Gelinas, Holly Fernandez Lynch, Barbara E. Bierer & I. Glenn Cohen - 2017 - Journal of Medical Ethics 43 (12):803-809.
    It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this (...)
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  4. How Clinical Trials Really Work Rethinking Research Ethics.Debra A. DeBruin, Joan Liaschenko & Anastasia Fisher - 2011 - Kennedy Institute of Ethics Journal 21 (2):121-139.
    Clinical trials are a central mechanism in the production of medical knowledge. They are the gold standard by which such knowledge is evaluated. They are widespread both in the United States and internationally; a National Institute of Health database reports over 106,000 active industry and government-sponsored trials (National Institutes of Health n.d.). They are an engine of the economy. The work of trials is complex; multiple people with diverse interests working across multiple settings simultaneously participate in (...)
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  5.  19
    Regulating clinical trials in India: The economics of ethics.Gerard Porter - 2018 - Developing World Bioethics 18 (4):365-374.
    The relationship between the ethical standards for the governance of clinical trials and market forces can be complex and problematic. This article uses India as a case study to explore this nexus. From the mid-2000s, India became a popular destination for foreign-sponsored clinical trials. The Indian government had sought to both attract clinical trials and ensure these would be run in line with internationally accepted ethical norms. Reports of controversial medical research, however, triggered debate (...)
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  6.  13
    Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries.Avram Denburg, Carlos Rodriguez-Galindo & Steven Joffe - 2016 - American Journal of Bioethics 16 (6):3-11.
    Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a “trial effect,” however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure—the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research—may function as a quality improvement lever, improving (...)
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  7.  15
    Nonconsensual Clinical Trials: A Foreseeable Risk of Offshoring Under Global Corporatism.Bethany Spielman - 2015 - Journal of Bioethical Inquiry 12 (1):101-106.
    This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented (...)
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  8.  18
    A Clinical Trials Manual From the Duke Clinical Research Institute: Lessons From a Horse Named Jim.Margaret B. Liu - 2010 - Wiley-Blackwell.
    As the_number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records (...)
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  9.  73
    Xenotransplantation Clinical Trials and the Need for Community Engagement.Michael K. Gusmano - 2022 - Hastings Center Report 52 (5):42-43.
    Hastings Center Report, Volume 52, Issue 5, Page 42-43, September–October 2022.
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  10.  18
    Clinical Trials of Xenotransplantation: Waiver of the Right to Withdraw from a Clinical Trial Should Be Required.Monique A. Spillman & Robert M. Sade - 2007 - Journal of Law, Medicine and Ethics 35 (2):265-272.
    Xenotransplantation is defined as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” Xenotransplantation has been viewed by desperate patients and their surgeons as a solution to the problem of the paucity of human organs available for transplantation. Foes of xenotransplantation argue that (...)
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  11.  16
    Clinical Trials of Xenotransplantation: Waiver of the Right to Withdraw from a Clinical Trial Should Be Required.Monique A. Spillman & Robert M. Sade - 2007 - Journal of Law, Medicine and Ethics 35 (2):265-272.
    Xenotransplantation pits clinical research ethics against public health needs because recipients must undergo long-term, perhaps life-long, surveillance for infectious diseases. This surveillance requirement is effectively an abrogation of the right to withdraw from a clinical trial. Ulysses contracts, which are advance directives for future care, may be an ethical mechanism by which to balance public health needs against limitation of individual rights.
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  12.  8
    Pragmatic Clinical Trial-Collateral Findings: Recognizing the Needs of Low-Resource Research Participants.Courtney A. Stewart, Kayla E. Cooper, Megan B. Raymond, Faith E. Fletcher & Vence L. Bonham - 2020 - American Journal of Bioethics 20 (1):19-21.
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  13.  57
    Clinical trials: two neglected ethical issues.A. Herxheimer - 1993 - Journal of Medical Ethics 19 (4):211-218.
    Ethical reasons are presented for requiring 1) that a proposal for a clinical trial should be accompanied by a thorough review of all previous trials that have examined the same and closely related questions, and 2) that a trial should be approved by a research ethics committee only if the investigator undertakes to register it in an appropriate register of clinical trials as soon as one exists.
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  14.  20
    Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy.Alex John London & Jonathan Kimmelman - 2019 - Hastings Center Report 49 (4):31-41.
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  15.  24
    Starting clinical trials of xenotransplantation--reflections on the ethics of the early phase.S. Welin - 2000 - Journal of Medical Ethics 26 (4):231-236.
    What kind of patients may be recruited to early clinical trials of xenotransplantation? This is discussed under the assumption that the risk of viral infection to the public is non-negligible. Furthermore, the conditions imposed by the Helsinki declaration are analysed. The conclusion is that only patients at risk of dying and with no alternative treatment available should be recruited to xenotransplantation trials in the early phase. For some of the less dangerous cell or islet cell xenotransplantation other (...)
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  16.  11
    Assessing Clinical Trial Informed Consent Comprehension in Non-Cognitively-Impaired Adults: A Systematic Review of Instruments.Laura D. Buccini, Don Iverson, Peter Caputi, Caroline Jones & Sheridan Gho - 2009 - Research Ethics 5 (1):3-8.
    This systematic review identifies and critically evaluates instruments that have been developed to measure clinical trial informed consent comprehension in non-cognitively-impaired adults. Literature searches were carried out on Medline, PsycInfo, CINHAL, ERIC, ScienceDirect, and Cochrane Library for English language articles published between January 1980 and September 2008. Instruments were excluded if they focused on consent onto paediatric trials, the construct under study was primarily capacity or competency, or the instrument was developed specifically for psychiatric or cognitively-impaired populations. Instruments (...)
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  17.  10
    Unapproved clinical trials in Russia: exception or norm?Petr Talantov, Ravil Niyazov, Galina Viryasova, Margarita Dranitsyna & Ilya Yasny - 2021 - BMC Medical Ethics 22 (1):1-8.
    Background In modern Russia, any clinical investigation of a pharmaceutical for use in humans is subject to prior evaluation and approval by the Ministry of Health and its Central Ethics Committee. Despite this, some researchers and trial sponsors fail to comply, this is particularly true in case of the studies initiated by domestic sponsors or sponsor-investigators and published in Russian language medical journals. This exploratory research aims to discover whether it is a sporadic non-compliance with regulations or a common (...)
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  18.  10
    Pragmatic clinical trials and the consent process.Blake Murdoch & Timothy Caulfield - 2018 - Research Ethics 14 (2):1-14.
    Pragmatic clinical trials are a relatively new methodological approach to the execution of clinical research that can increase research efficiency and provide access to unique data. Some have suggested that the costs and delays associated with obtaining informed consent could make PCTs difficult or even impossible to execute. Alternative consent models have been proposed, some of which lower standards of disclosure, delay consent, or waive it altogether. We analyze the permissibility of changes to informed consent in the (...)
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  19.  36
    Cancer clinical trial participants' assessment of risk and benefit.Connie M. Ulrich, Sarah J. Ratcliffe, Gwenyth R. Wallen, Qiuping Zhou, Kathleen Knafl & Christine Grady - 2016 - AJOB Empirical Bioethics 7 (1):8-16.
  20.  8
    Interpreting clinical trial results by deductive reasoning: In search of improved trial design.Sven Kurbel & Slobodan Mihaljević - 2017 - Bioessays 39 (10):1700103.
    Clinical trial results are often interpreted by inductive reasoning, in a trial design-limited manner, directed toward modifications of the current clinical practice. Deductive reasoning is an alternative in which results of relevant trials are combined in indisputable premises that lead to a conclusion easily testable in future trials.
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  21. Clinical Trials and the African Person: A Quest to Re-Conceptualize Responsibility.Ike V. Iyioke - 2018 - Brill | Rodopi.
    _Clinical Trials and the African Person_ offers an account of the African notion of the self/person within the clinical trials context. As opposed to autonomy-based principlism, this other-regarding/communalist perspective is touted as the preferred alternative model particularly in multicultural settings.
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  22.  9
    Clinical Trials Registries: A Reform that is Past Due.Jennifer L. Gold & David M. Studdert - 2005 - Journal of Law, Medicine and Ethics 33 (4):811-820.
    Several high-profile episodes have recently thrust drug safety and the pharmaceutical industry's practices into the spotlight. Merck's recall of the drug Vioxx, for instance, was a major news event. GlaxoSmithKline's suppression of data linking suicidal behavior among children to Paxil also galvanized tremendous public attention. What differentiates these events from the usual evolving process of scientific knowledge, and marks them with an aura of “scandal,” are questions about the propriety of corporate behavior. Who knew what, and when did they know (...)
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  23.  5
    Clinical Trials Registries: A Reform That is Past Due.Jennifer L. Gold & David M. Studdert - 2005 - Journal of Law, Medicine and Ethics 33 (4):811-820.
    Several high-profile episodes have recently thrust drug safety and the pharmaceutical industry's practices into the spotlight. Merck's recall of the drug Vioxx, for instance, was a major news event. GlaxoSmithKline's suppression of data linking suicidal behavior among children to Paxil also galvanized tremendous public attention. What differentiates these events from the usual evolving process of scientific knowledge, and marks them with an aura of “scandal,” are questions about the propriety of corporate behavior. Who knew what, and when did they know (...)
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  24.  19
    Clinical trials and scid row: The ethics of phase 1 trials in the developing world.Jonathan Kimmelman - 2007 - Developing World Bioethics 7 (3):128–135.
    ABSTRACTRelatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer’s most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have (...)
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  25.  27
    Consent for participating in clinical trials - Is it really informed?Teodora Alexa‐Stratulat, Marius Neagu, Anca‐Iulia Neagu, Ioana Dana Alexa & Beatrice Gabriela Ioan - 2018 - Developing World Bioethics 18 (3):299-306.
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  26.  57
    Adapt to Translate – Adaptive Clinical Trials and Biomedical Innovation.Daria Jadreškić - 2021 - European Journal of Analytic Philosophy 17 (2):(SI3)5-24.
    The article presents the advantages and limitations of adaptive clinical trials for assessing the effectiveness of medical interventions and specifies the conditions that contributed to their development and implementation in clinical practice. I advance two arguments by discussing different cases of adaptive trials. The normative argument is that responsible adaptation should be taken seriously as a new way of doing clinical research insofar as a valid justification, sufficient understanding, and adequate operational conditions are provided. The (...)
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  27.  53
    Clinical trials: Active control vs placebo — what is ethical?Jacek Spławiński & Jerzy Kuźniar - 2004 - Science and Engineering Ethics 10 (1):73-79.
    The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs: superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of μ (the difference between a tested drug and comparator) ≤ 0 against μ > 0; the latter tests the null hypothesis of μ ≤ - Δ against, μ > - Δ, where Δ is the clinical difference from the comparator. In a (...)
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  28.  11
    Clinical trials and the origins of pharmaceutical fraud: Parke, Davis & Company, virtue epistemology, and the history of the fundamental antagonism.Joseph M. Gabriel & Bennett Holman - 2020 - History of Science 58 (4):533-558.
    This paper describes one possible origin point for fraudulent behavior within the American pharmaceutical industry. We argue that during the late nineteenth century therapeutic reformers sought to promote both laboratory science and increasingly systematized forms of clinical experiment as a new basis for therapeutic knowledge. This process was intertwined with a transformation in the ethical framework in which medical science took place, one in which monopoly status was replaced by clinical utility as the primary arbiter of pharmaceutical legitimacy. (...)
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  29.  10
    Clinical trials of germline gene editing: The exploitation problem.Erik Malmqvist - 2021 - Bioethics 35 (7):688-695.
    Bioethics, Volume 35, Issue 7, Page 688-695, September 2021.
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  30.  24
    Clinical Trials Without Consent?Scott Y. H. Kim - 2016 - Perspectives in Biology and Medicine 59 (1):132-146.
    The routine practice of clinical research involving patient-subjects without informed consent prior to 1966 unquestionably was unethical. Does it follow that all clinical research involving competent adult patient-subjects is unethical without informed consent?In his landmark 1966 paper, Henry Beecher noted that of the 50 example studies he had originally compiled in preparation for that paper, only two even mentioned consent, and he observed further that mention of consent is “meaningless unless one knows how fully the patient was informed”. (...)
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  31. Clinical Trials in Latin America: Where Ethics and Business Clash.Nuria Homedes & Antonio Ugalde (eds.) - 2014 - Cham: Imprint: Springer.
    The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin (...)
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  32.  3
    Clinical trials and scid row: The ethics of phase 1 trials in the developing world.Jonathan Kimmelman - 2007 - Developing World Bioethics 7 (3):128-135.
    ABSTRACTRelatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer’s most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have (...)
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  33.  24
    Randomized Clinical Trials in Psychotherapy Outcome Research.Edward Erwin - 2006 - Philosophy of Science 73 (2):135-152.
    This paper discusses several philosophical problems with the use of randomized clinical trials in psychotherapy outcome research. The problems include: the impermanence problem, the identification problem, and idiographic problems. The paper concludes with an assessment of the overall case for and against the use of RCTs in psychotherapy outcome research.
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  34.  15
    Disclosing Clinical Trial Results: Publicity, Significance and Independence.S. Matthew Liao, Mark Sheehan & Steve Clarke - 2009 - American Journal of Bioethics 9 (8):3-5.
    Participants in some clinical trials are at risk of being harmed and sometimes are seriously harmed as a result of not being provided with available, relevant risk information. We argue that this situation is unacceptable and that there is a moral duty to disclose all adverse clinical trial results to participants in clinical trials. This duty is grounded in the human right not to be placed at risk of harm without informed consent. We consider objections (...)
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  35. Clinical Trials and Drug Promotion.Jon Jureidini, Leemon McHenry & Peter Mansfield - 2008 - International Journal of Risk and Safety in Medicine 20:73-81.
    Selective reporting is prevalent in the medical literature, particularly in industry-sponsored research. In this paper, we expose selective reporting that is not evident without access to internal company documents. The published report of study 329 of paroxetine in adolescents sponsored by GlaxoSmithKline claims that “paroxetine is generally well tolerated and effective for major depression in adolescents”. By contrast, documents obtained during litigation reveal that study 329 was negative for efficacy on all 8 protocol specified outcomes and positive for harm.
     
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  36.  94
    Clinical trials--a brave new partnership?H. Thornton - 1994 - Journal of Medical Ethics 20 (1):19-25.
    The need for informed consent is considered from the patient's viewpoint by an examination of the shortcomings of the UK Ductal Carcinoma In Situ (DCIS) trial and its failure satisfactorily to accrue both profession and patient. The impersonal, negative aspects of the informed consent process in the research situation are contrasted with the positive benefits of confidence fostered by the traditional doctor/patient relationship. The need for new research with a partnership between patient and profession, the necessity for rigorous re-assessment of (...)
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  37.  19
    Intergenerational monitoring in clinical trials of germline gene editing.Bryan Cwik - 2020 - Journal of Medical Ethics 46 (3):183-187.
    Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational (...)
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  38.  27
    Clinical trials: deliberations on their essence and value.Franz A. Schelling - 2004 - Journal of Evaluation in Clinical Practice 10 (2):291-296.
  39. Failures in Clinical Trials in the European Union: Lessons from the Polish Experience.Marcin Waligora - 2013 - Science and Engineering Ethics 19 (3):1087-1098.
    When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good (...) Practice, these irregularities occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. (shrink)
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  40.  3
    How Clinical Trial Data Sharing Platforms Can Advance the Study of Biomarkers.Rebecca Li & Ida Sim - 2019 - Journal of Law, Medicine and Ethics 47 (3):369-373.
    Although data sharing platforms host diverse data types the features of these platforms are well-suited to facilitating biomarker research. Given the current state of biomarker discovery, an innovative paradigm to accelerate biomarker discovery is to utilize platforms such as Vivli to leverage researchers' abilities to integrate certain classes of biomarkers.
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  41.  61
    Monitoring in clinical trials: benefit or bias?Cecilia Nardini - 2013 - Theoretical Medicine and Bioethics 34 (4):259-274.
    Monitoring ongoing clinical trials for early signs of effectiveness is an option for improving cost-effectiveness of trials that is becoming increasingly common. Alongside the obvious advantages made possible by monitoring, however, there are some downsides. In particular, there is growing concern in the medical community that trials stopped early for benefit tend to overestimate treatment effect. In this paper, I examine this problem from the point of view of statistical methodology, starting from the observation that the (...)
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  42.  84
    Bayesian versus frequentist clinical trials.David Teira - 2011 - In Gifford Fred (ed.), Philosophy of Medicine. Amsterdam: Elsevier. pp. 255-297.
    I will open the first part of this paper by trying to elucidate the frequentist foundations of RCTs. I will then present a number of methodological objections against the viability of these inferential principles in the conduct of actual clinical trials. In the following section, I will explore the main ethical issues in frequentist trials, namely those related to randomisation and the use of stopping rules. In the final section of the first part, I will analyse why (...)
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  43.  4
    Clinical Trial Transparency: The FDA Should and Can Do More.Amy Kapczynski & Jeanie Kim - 2017 - Journal of Law, Medicine and Ethics 45 (s2):33-38.
    The Blueprint for Transparency at the FDA recommends that the FDA proactively release more clinical trial data. We show that the FDA possesses the legal authority to act on this recommendation, and describe several reasons that the agency should do so. In particular, the primary existing route for researchers to obtain access to this data, the Freedom of Information Act, has important limits, as our own recent experience shows.
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  44. Competing Clinical Trials in the Same Institution: Ethical Issues in Subject Selection and Informed Consent.Elisa J. Gordon & Kenneth C. Micetich - 2002 - IRB: Ethics & Human Research 24 (2):1.
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  45.  21
    Placebo-controlled clinical trials: how trial documents justify the use of randomisation and placebo.Tapani Keränen, Arja Halkoaho, Emmi Itkonen & Anna-Maija Pietilä - 2015 - BMC Medical Ethics 16 (1):2.
    Randomised clinical trials involve procedures such as randomisation, blinding, and placebo use, which are not part of standard medical care. Patients asked to participate in RCTs often experience difficulties in understanding the meaning of these and their justification.
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  46.  10
    Terminating clinical trials without sufficient subjects.Lianne Damen, Frans van Agt, Theo de Boo & Frans Huysmans - 2012 - Journal of Medical Ethics 38 (7):413-416.
    Medical research involving human subjects can be risky and burdensome. Therefore, such research must be reviewed and approved by a Research Ethics Committee (REC). To guarantee the safety of the subjects, it is very important that these studies be conducted in accordance with the approved protocol. An important issue in this respect is whether studies include the requisite number of subjects based on the research question. The research question is unlikely to be answered reliably if the requisite number of subjects (...)
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  47.  64
    Clinical trials -- a brave new partnership: a response to Mrs. Thornton.M. Baum - 1994 - Journal of Medical Ethics 20 (1):23-25.
    In this commentary on the previous paper it is explained that screen-detected Duct Carcinoma In Situ is effectively a new disease of unknown natural history. It is therefore impossible that 'the doctor knows best' and it is therefore both in the patient and the public's best interests that such cases are submitted to the rigours of the randomised controlled trial. Inevitably this brings the ethical dilemma of how to explain to patients the uncertainty and how to involve them in a (...)
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  48. Distributive justice and clinical trials in the third world.D. R. Cooley - 2001 - Theoretical Medicine and Bioethics 22 (3):151-167.
    One of the arguments against conducting human subject trials in the Third World adopts a distributive justice principle found in a commentary of the CIOM'S Eighth Guideline for international research on human subjects. Critics argue that non-participant members of the community in which the trials are conducted are exploited because sponsoring agencies do not ensure that the products developed have been made reasonably available to these individuals. I argue that the distributive principle's wording is too vague and ambiguous (...)
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  49.  15
    Regulating trust in pediatric clinical trials.Wim Pinxten, Herman Nys & Kris Dierickx - 2008 - Medicine, Health Care and Philosophy 11 (4):439-444.
    The participation of minors in clinical trials is essential to provide safe and effective medical care to children. Because few drugs have been tested in children, pediatricians are forced to prescribe medications off-label with uncertain efficacy and safety. In this article, we analyze how the enrollment of minors in clinical trials is negotiated within relationships of mutual trust between clinicians, minors, and their parents. After a brief description of the problems associated with involving minors in (...) research, we consider how existing “relationships of trust” can be used as a place where the concerns of research subjects can be more fully discussed and addressed. Building on the tacit recognition of trust found in The European Clinical Trials Directive we make policy recommendations that allow for clearer, more ethically informed guidelines for enrolling minors in clinical research. (shrink)
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  50.  15
    Clinical Trials Cannot Substitute for Health System Strengthening Initiatives or Specifically Designed Health Policy and Systems Research.Kwaku Poku Asante, Caroline Jones, Sodiomon Bienvenu Sirima & Sassy Molyneux - 2016 - American Journal of Bioethics 16 (6):24-26.
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