Literature DB >> 19247887

What is the best standard for the standard of care in clinical research?

Rieke van der Graaf1, Johannes J M van Delden.   

Abstract

During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate. Current international research ethics guidelines contain a wide variety of standards for the standard of care--including the provision of the highest attainable, the best available, the best current, a proven, and an established effective treatment. In this article, we systematically review the currently used standards and argue that none of the current standards is adequate to serve as a universal standard for the standard of care. Alex London has made a substantial proposal for a universal standard, but universally adopting his standard is problematic. In this article, we propose a revised version of London's standard.

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Year:  2009        PMID: 19247887     DOI: 10.1080/15265160802654129

Source DB:  PubMed          Journal:  Am J Bioeth        ISSN: 1526-5161            Impact factor:   11.229


  7 in total

Review 1.  Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

Authors:  Kenneth E Freedland; David C Mohr; Karina W Davidson; Joseph E Schwartz
Journal:  Psychosom Med       Date:  2011-05-02       Impact factor: 4.312

Review 2.  The principle of equipoise in pediatric drug trials.

Authors:  Kim Chau; Gideon Koren
Journal:  Paediatr Drugs       Date:  2015-02       Impact factor: 3.022

3.  Standard of care for COVID-19 in randomized clinical trials registered in trial registries and published in preprint servers and scholarly journals: a cross-sectional study.

Authors:  Mahir Fidahic; Danijela Nujic; Marta Civljak; Renata Runjic; Filipa Markotic; Marin Vidak; Livia Puljak
Journal:  BMC Med Res Methodol       Date:  2022-06-17       Impact factor: 4.612

4.  Equipoise, standard of care and consent: responding to the authorisation of new COVID-19 treatments in randomised controlled trials.

Authors:  Soren Holm; Jonathan Lewis; Rafael Dal-Ré
Journal:  J Med Ethics       Date:  2022-05-23       Impact factor: 5.926

5.  It's Time: The Case for PrEP as an Active Comparator in HIV Biomedical Prevention Trials.

Authors:  Bridget Haire
Journal:  J Bioeth Inq       Date:  2014-07-20       Impact factor: 1.352

6.  Ethical considerations in determining standard of prevention packages for HIV prevention trials: examining PrEP.

Authors:  Bridget Haire; Morenike Oluwatoyin Folayan; Catherine Hankins; Jeremy Sugarman; Sheena McCormack; Gita Ramjee; Mitchell Warren
Journal:  Dev World Bioeth       Date:  2013-05-31       Impact factor: 2.294

Review 7.  A review and definition of 'usual care' in genetic counseling trials to standardize use in research.

Authors:  Barbara B Biesecker; Sarah E Lillie; Laura M Amendola; Katherine E Donohue; Kelly M East; Ann Katherine M Foreman; Marian J Gilmore; Veronica Greve; Billie Liangolou; Julianne M O'Daniel; Jacqueline A Odgis; Shannon Rego; Bradley Rolf; Sarah Scollon; Sabrina A Suckiel; Jamilyn Zepp; Galen Joseph
Journal:  J Genet Couns       Date:  2020-12-05       Impact factor: 2.537

  7 in total

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