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Utility – Are Clinical Trial Results Useful?

The utility of a trial raises the question — how broadly can the study results be applied? Researchers create very strict requirements for selecting trial participants and then they demand that they follow very exacting procedures during the study. These steps make sense — they optimize the effectiveness of a treatment, but, they also have an undesirable downside. The results only apply to those specially selected subjects — and that most likely will be a tiny proportion of the patients in the more broadly based society. Furthermore, only volunteers who give their written informed consent can become research subjects, which has a crippling effect on the usefulness of all clinical trials. The results of a clinical trial may not apply to the people unwilling to take the risks inherent in a clinical trial. In addition subjects often have to be recruited and each recruitment method (newspaper advertisements, appeals by the investigators, payment offers, etc.) may draw a unique set of people. In fact, it's possible to describe most volunteers as the “UN” people. They tend to be unemployed, uninsured, unhealthy and unselfish.

Keywords

External validity generalizability informed consent subject selection study volunteers 

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Chapter 10 — Utility

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© Springer Science + Business Media B.V 2009

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