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10.20529/IJME.2021.020 http://scihub22266oqcxt.onion/10.20529/IJME.2021.020 33908354!ä!33908354 Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=33908354&cmd=llinks): Failed to open stream: HTTP request failed! 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The continued use of placebo arms in COVID-19 vaccine trials does not adequately protect the well-being of participants |pdf=|usr=}}{{33908354}} gab.com Text The continued use of placebo arms in COVID-19 vaccine trials does not adequately protect the well-being of participants JO: Indian J Med Ethics http://www.kidney.de/pget.php?&tw=1&pmid=33908354 #FOAvip Covid-19 vaccines are a critical tool for controlling the pandemic. While safe and effective vaccines have been developed, research is expected to continue for many years regarding the optimal implementation of existing vaccines in specific settings, and the development of second-generation vaccines that may offer advantages in terms of either efficacy or ease of implementation. Given this context, some commentators have argued that new Covid vaccine trials should be able to use placebo controls, and that existing studies should be able to continue with blinded participants in order to collect high quality, unbiased data. Using international ethics guidance documents, this paper argues against placebo controls, given the existence of proven effective interventions, and against protracted blinding once safety and efficacy milestones have been met. Instead, it advocates for study designs that allow for direct comparison between approved and experimental vaccines, which facilitates both data collection and greater access to vaccines. Twit Text FOAVip The continued use of placebo arms in COVID-19 vaccine trials does not adequately protect the well-being of participants ????Indian J Med Ethics http://www.kidney.de/pget.php?&tw=1&pmid=33908354 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33908354 #FOAvip English Wikipedia <ref>{{Cite pmid|33908354}}</ref> The continued use of placebo arms in COVID-19 vaccine trials does not adequately protect the well-being of participants #MMPMID33908354 Haire B Indian J Med Ethics 2021[Apr]; VI (2): 1-10 PMID33908354show ga Covid-19 vaccines are a critical tool for controlling the pandemic. While safe and effective vaccines have been developed, research is expected to continue for many years regarding the optimal implementation of existing vaccines in specific settings, and the development of second-generation vaccines that may offer advantages in terms of either efficacy or ease of implementation. Given this context, some commentators have argued that new Covid vaccine trials should be able to use placebo controls, and that existing studies should be able to continue with blinded participants in order to collect high quality, unbiased data. Using international ethics guidance documents, this paper argues against placebo controls, given the existence of proven effective interventions, and against protracted blinding once safety and efficacy milestones have been met. Instead, it advocates for study designs that allow for direct comparison between approved and experimental vaccines, which facilitates both data collection and greater access to vaccines. |*Guidelines as Topic[MESH] |*Human Rights[MESH] |Biomedical Research/*standards[MESH] |COVID-19 Vaccines/*standards[MESH] |COVID-19/*prevention & control[MESH] |Ethics, Medical[MESH] |Humans[MESH] |Pandemics[MESH] |Patient Safety/*standards[MESH] |Placebos/*standards[MESH]The continued use of placebo arms in COVID-19 vaccine trials does not (epmc).pdf DeepDyve Pubget Overpricing