Literature DB >> 19099004

The myth of equipoise in phase 1 clinical trials.

Adil E Shamoo1.   

Abstract

Phase 1 clinical research trials using healthy volunteers are conducted for the sole purpose of serving the public good (a utilitarian concept). The literature on equipoise analysis does not exclude phase 1 trials with controls or healthy volunteers from the claim of being in "equipoise." The continued perpetuation of this ethically and scientifically invalid concept undermines the ethics of research with human subjects.

Entities:  

Mesh:

Year:  2008        PMID: 19099004      PMCID: PMC2605120     

Source DB:  PubMed          Journal:  Medscape J Med        ISSN: 1934-1997


  23 in total

1.  What makes clinical research ethical?

Authors:  E J Emanuel; D Wendler; C Grady
Journal:  JAMA       Date:  2000 May 24-31       Impact factor: 56.272

Review 2.  The recruitment of normal healthy volunteers: a review of the literature on the use of financial incentives.

Authors:  Carl L Tishler; Suzanne Bartholomae
Journal:  J Clin Pharmacol       Date:  2002-04       Impact factor: 3.126

3.  Phase I cancer trials. A collusion of misunderstanding.

Authors:  M Miller
Journal:  Hastings Cent Rep       Date:  2000 Jul-Aug       Impact factor: 2.683

4.  Cohort-specific consent: an honest approach to phase 1 clinical cancer studies.

Authors:  Benjamin Freedman
Journal:  IRB       Date:  1990 Jan-Feb

5.  Clarifying the ethics of clinical research: a path toward avoiding the therapeutic misconception.

Authors:  Paul S Appelbaum
Journal:  Am J Bioeth       Date:  2002       Impact factor: 11.229

6.  A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials.

Authors:  Franklin G Miller; Howard Brody
Journal:  Hastings Cent Rep       Date:  2003 May-Jun       Impact factor: 2.683

7.  Guinea-pigging: healthy human subjects for drug safety trials are in demand. But is it a living?

Authors:  Carl Elliott
Journal:  New Yorker       Date:  2008-01-07

8.  Ethics of phase 1 oncology studies: reexamining the arguments and data.

Authors:  Manish Agrawal; Ezekiel J Emanuel
Journal:  JAMA       Date:  2003-08-27       Impact factor: 56.272

9.  Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS vaccine evaluation group NIAID-sponsored Phase I and II clinical trials.

Authors:  P B Gilbert; Y-L Chiu; M Allen; D N Lawrence; C Chapdu; H Israel; D Holman; M C Keefer; M Wolff; S E Frey
Journal:  Vaccine       Date:  2003-06-20       Impact factor: 3.641

10.  Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development.

Authors:  James F Fries; Eswar Krishnan
Journal:  Arthritis Res Ther       Date:  2004-03-18       Impact factor: 5.156

View more
  4 in total

1.  A reader responds to "The myth of equipoise in phase 1 clinical trials".

Authors:  John H Noble
Journal:  Medscape J Med       Date:  2008-12-15

Review 2.  Randomized controlled trials: Ethical and scientific issues in the choice of placebo or active control.

Authors:  Joseph Ogirima Ovosi; Muhammed Sani Ibrahim; Beatrice Ohunene Bello-Ovosi
Journal:  Ann Afr Med       Date:  2017 Jul-Sep

3.  Taking the principle of the primacy of the human being seriously.

Authors:  Joanna Różyńska
Journal:  Med Health Care Philos       Date:  2021-07-27

4.  Safety, pharmacokinetics and pharmacodynamics of idarucizumab, a specific dabigatran reversal agent in healthy Japanese volunteers: a randomized study.

Authors:  Masahiro Yasaka; Ippei Ikushima; Akiko Harada; Susumu Imazu; Atsushi Taniguchi; Stephen Norris; Dietmar Gansser; Joachim Stangier; Michael Schmohl; Paul A Reilly
Journal:  Res Pract Thromb Haemost       Date:  2017-08-05
  4 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.