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27 - Clinical trials

Published online by Cambridge University Press:  30 October 2009

By
Richard E. Ashcroft  and
A. M. Viens
Edited by
Peter A. Singer  and
A. M. Viens
Richard E. Ashcroft
Affiliation:
Professor University of London, UK
A. M. Viens
Affiliation:
Faculty of Philosophy University of Oxford, UK
Peter A. Singer
Affiliation:
University of Toronto
A. M. Viens
Affiliation:
University of Oxford
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Summary

Dr. D, a clinical investigator, is conducting a clinical trial on a recently developed therapy for the treatment of a progressive neurodegenerative disorder. While initial results in a previous study generally appeared promising, the therapy has been associated with fatal bone marrow suppression in approximately 1% of patients. A colleague pediatrician, who has a patient with this neurodegenerative disorder, asks Dr. D if the child can be enrolled in the clinical trial. There are no data in the literature about this therapy having ever been used or tested in children with this condition, and Dr. D wonders whether the child should be included in the trial.

What are clinical trials?

Clinical trials are scientific evaluations of medical interventions for the treatment of somatic or psychological conditions that provide an analysis of the quality, safety, and efficacy of particular products, or a method of evaluating two products for their comparative value. While clinical trials are most often used to test therapeutic pharmaceutical products, they can also be utilized to evaluate medical devices or surgical procedures, plus other preventive, screening, detection, and non-pharmacological therapeutic products/methods.

Clinical trials influence clinical practice by providing vital information to clinicians and patients to use in assessing appropriate treatment options. Clinical trials allow for the generation of sound empirical evidence that individuals can use to address important questions concerning the benefits and harms of particular therapies in a scientifically rigorous and ethical way.

Type
Chapter
Information
The Cambridge Textbook of Bioethics , pp. 201 - 206
Publisher: Cambridge University Press
Print publication year: 2008

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References

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