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Placebo use in vaccine trials: recommendations of a WHO expert panel.

التفاصيل البيبلوغرافية
العنوان: Placebo use in vaccine trials: recommendations of a WHO expert panel.
المؤلفون: Rid A; Department of Social Science, Health & Medicine, King's College London, Strand, London WC2R 2LS, United Kingdom. Electronic address: annette.rid@kcl.ac.uk., Saxena A; Knowledge, Ethics and Research, World Health Organization, Geneva, Switzerland., Baqui AH; International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States., Bhan A; Ethical, Social and Cultural Program for Global Health, University of Toronto, Toronto, ON, Canada., Bines J; Murdoch Childrens Research Institute, University of Melbourne, Parkville, VIC, Australia., Bouesseau MC; Service Delivery and Safety, World Health Organization, Geneva, Switzerland., Caplan A; Division of Medical Ethics, NYU School of Medicine, New York, NY, United States., Colgrove J; Mailman School of Public Health, Columbia University, New York, NY, United States., Dhai A; Steve Biko Centre for Bioethics, University of Witwatersrand, Johannesburg, South Africa., Gomez-Diaz R; Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Ciudad de Mexico, D.F., Mexico., Green SK; Ethical, Social and Cultural Program for Global Health, St. Michael's Hospital and University of Toronto, Toronto, ON, Canada., Kang G; Christian Medical College, Vellore, Tamil Nadu, India., Lagos R; Hospital de Niños Roberto del Río, Santiago de Chile, Chile., Loh P; Melbourne Law School, University of Melbourne, Carlton, VIC, Australia., London AJ; Department of Philosophy, Carnegie Mellon University, Pittsburgh, PA, United States., Mulholland K; London School of Hygiene and Tropical Medicine, London, United Kingdom., Neels P; Vaccine Advice BVBA, Zoersel, Belgium., Pitisuttithum P; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand., Sarr SC; Ministry of Health and Social Action 1, Dakar-Fann, Senegal., Selgelid M; Centre for Human Bioethics, Monash University, Monash, VIC, Australia., Sheehan M; The Ethox Centre, University of Oxford, Oxford, United Kingdom., Smith PG; Medical Research Council (MRC) Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.
المصدر: Vaccine [Vaccine] 2014 Aug 20; Vol. 32 (37), pp. 4708-12. Date of Electronic Publication: 2014 Apr 25.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
أسماء مطبوعة: Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
مواضيع طبية MeSH: Placebos* , Research Design* , Vaccines*, Randomized Controlled Trials as Topic/*ethics, Guidelines as Topic ; World Health Organization
مستخلص: Vaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of unvaccinated controls (with or without placebo) when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease.
(Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.)
التعليقات: Comment in: Vaccine. 2017 Mar 1;35(9):1211. (PMID: 25804705)
References: Fed Regist. 2008 Apr 28;73(82):22800-16. (PMID: 18567164)
N Engl J Med. 2012 Dec 13;367(24):2284-95. (PMID: 23136909)
Lancet. 2014 Jun 21;383(9935):2136-43. (PMID: 24629994)
Lancet. 2005 Jan 1-7;365(9453):43-52. (PMID: 15643700)
BMC Med Ethics. 2013 Dec 01;14:48. (PMID: 24289542)
Lancet Infect Dis. 2011 Feb;11(2):102-9. (PMID: 21237715)
Lancet. 2012 Dec 15;380(9859):2197-223. (PMID: 23245608)
Clin Microbiol Infect. 2012 Oct;18 Suppl 5:57-63. (PMID: 22882248)
Bull Med Ethics. 2002 Oct;(182):17-23. (PMID: 14983848)
Mem Inst Oswaldo Cruz. 2011 Dec;106(8):907-11. (PMID: 22241109)
JAMA. 2013 Nov 27;310(20):2191-4. (PMID: 24141714)
Indian J Lepr. 1998 Oct-Dec;70(4):369-88. (PMID: 10189587)
Lancet. 2005 Mar 26-Apr 1;365(9465):1139-46. (PMID: 15794968)
معلومات مُعتمدة: 001 International WHO_ World Health Organization; MR/K012126/1 United Kingdom MRC_ Medical Research Council
فهرسة مساهمة: Keywords: Ethics; International research; Placebo controls; Risk; Trial design; Vaccine trials
المشرفين على المادة: 0 (Placebos)
0 (Vaccines)
تواريخ الأحداث: Date Created: 20140429 Date Completed: 20150309 Latest Revision: 20220129
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC4157320
DOI: 10.1016/j.vaccine.2014.04.022
PMID: 24768580
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2518
DOI:10.1016/j.vaccine.2014.04.022