Literature DB >> 14986768

Using empirical data to inform the ethical evaluation of placebo controlled trials.

Jeremy Sugarman1.   

Abstract

There has been considerable debate about the ethical acceptability of using placebo-controls in clinical research. Although this debate has been rich in rhetoric, considering that much of this research is predicated upon the assumption that data from this research is vital to clinical decision-making, it is ironic that researchers have introduced little data into these discussions. Using some published research concerning the use of placebo-controls in clinical research in hypertension and psychiatric drug trials, I suggest some ways that such data might be incorporated into the ethical analysis concerning placebo use in clinical trials. This approach promises to be important for enhancing conceptual and scientific understanding as well as public policy decision-making.

Entities:  

Keywords:  Biomedical and Behavioral Research; Empirical Approach

Mesh:

Substances:

Year:  2004        PMID: 14986768     DOI: 10.1007/s11948-004-0059-8

Source DB:  PubMed          Journal:  Sci Eng Ethics        ISSN: 1353-3452            Impact factor:   3.525


  18 in total

1.  Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases.

Authors:  S S Ellenberg; R Temple
Journal:  Ann Intern Med       Date:  2000-09-19       Impact factor: 25.391

Review 2.  Ethics in the design and conduct of clinical trials.

Authors:  Jeremy Sugarman
Journal:  Epidemiol Rev       Date:  2002       Impact factor: 6.222

3.  Practitioners and clinical trials.

Authors:  Eugene V Boisaubin
Journal:  J Gen Intern Med       Date:  2002-09       Impact factor: 5.128

4.  Placebo orthodoxy in clinical research. II: Ethical, legal, and regulatory myths.

Authors:  B Freedman; K C Glass; C Weijer
Journal:  J Law Med Ethics       Date:  1996       Impact factor: 1.718

5.  The continuing unethical use of placebo controls.

Authors:  K J Rothman; K B Michels
Journal:  N Engl J Med       Date:  1994-08-11       Impact factor: 91.245

6.  The use of placebo controls.

Authors:  H R Taylor
Journal:  N Engl J Med       Date:  1995-01-05       Impact factor: 91.245

Review 7.  National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders.

Authors:  Dennis S Charney; Charles B Nemeroff; Lydia Lewis; Sally K Laden; Jack M Gorman; Eugene M Laska; Michael Borenstein; Charles L Bowden; Arthur Caplan; Graham J Emslie; Dwight L Evans; Barbara Geller; Lenore E Grabowski; Jay Herson; Ned H Kalin; Paul E Keck; Irving Kirsch; K Ranga R Krishnan; David J Kupfer; Robert W Makuch; Franklin G Miller; Herbert Pardes; Robert Post; Mildred M Reynolds; Laura Roberts; Jerrold F Rosenbaum; Donald L Rosenstein; David R Rubinow; A John Rush; Neal D Ryan; Gary S Sachs; Alan F Schatzberg; Susan Solomon
Journal:  Arch Gen Psychiatry       Date:  2002-03

8.  Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: an analysis of the Food and Drug Administration database.

Authors:  A Khan; H A Warner; W A Brown
Journal:  Arch Gen Psychiatry       Date:  2000-04

9.  Comparison of ivermectin and diethylcarbamazine in the treatment of onchocerciasis.

Authors:  B M Greene; H R Taylor; E W Cupp; R P Murphy; A T White; M A Aziz; H Schulz-Key; S A D'Anna; H S Newland; L P Goldschmidt
Journal:  N Engl J Med       Date:  1985-07-18       Impact factor: 91.245

10.  Suicide risk in placebo vs active treatment in placebo-controlled trials for schizophrenia.

Authors:  Jitschak G Storosum; Barbara J van Zwieten; Tamar Wohlfarth; Lieuwe de Haan; Arif Khan; Wim van den Brink
Journal:  Arch Gen Psychiatry       Date:  2003-04
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  1 in total

Review 1.  Placebo: its action and place in health research today--summary and conclusions.

Authors:  Raymond E Spier
Journal:  Sci Eng Ethics       Date:  2004-01       Impact factor: 3.525

  1 in total

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