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The obligation to ensure access to beneficial treatments for research participants at the conclusion of clinical trials

In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 697--710 (2008)

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  1. The Need for Systematic Reviews of Reasons.Neema Sofaer & Daniel Strech - 2012 - Bioethics 26 (6):315-328.
    There are many ethical decisions in the practice of health research and care, and in the creation of policy and guidelines. We argue that those charged with making such decisions need a new genre of review. The new genre is an application of the systematic review, which was developed over decades to inform medical decision-makers about what the totality of studies that investigate links between smoking and cancer, for example, implies about whether smoking causes cancer. We argue that there is (...)
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  • La obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación.Ignacio Mastroleo - 2012 - Dissertation, Universidad de Buenos Aires
    Todos los días se prueban nuevos psicofármacos, tratamientos para el VIH/SIDA o el cáncer, entre otras enfermedades. Algunos de esos tratamientos son lo suficientemente exitosos como para cronificar enfermedades antes consideradas mortales, como los antirretrovirales para el VIH/SIDA o el imatinib para la leucemia mieloide a principios del 2000. No obstante, antes de que puedan ser comercializados o estar disponibles en los sistemas de salud pública, deben pasar por una serie de rigurosas pruebas de calidad, seguridad y eficacia. Estas pruebas (...)
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  • Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not Be Ensured to Research Participants: A Systematic Review.N. Sofaer & D. Strech - 2011 - Public Health Ethics 4 (2):160-184.
    Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug (...)
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  • The Diverse Ethics of Translational Research.Neema Sofaer & Nir Eyal - 2010 - American Journal of Bioethics 10 (8):19-30.
    Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research (now called T1 ). Whether or not T1 has these features, translational research beyond approval (...)
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  • Care After Research: A Framework for NHS RECs.Neema Sofaer, Penney Lewis & Hugh Davies - 2012 - Health Research Authority.
    Care after research is for participants after they have finished the study. Often it is NHS-provided healthcare for the medical condition that the study addresses. Sometimes it includes the study intervention, whether funded and supplied by the study sponsor, NHS or other party. The NHS has the primary responsibility for care after research. However, researchers are responsible at least for explaining and justifying what will happen to participants once they have finished. RECs are responsible for considering the arrangements. There are (...)
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