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QJM Advance Access originally published online on February 20, 2006
QJM 2006 99(3):177-179; doi:10.1093/qjmed/hcl015
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© The Author 2006. Published by Oxford University Press on behalf of the Association of Physicians. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Commentary

Balancing the morbidity benefit of a novel treatment with the potential for harm

A. Owen

From the Department of Cardiology, Kent and Canterbury Hospital, Canterbury, UK

Address correspondence to Dr A. Owen, Department of Cardiology, Kent and Canterbury Hospital, Ethelbert Road, Canterbury CT1 3NG.

The first 10% of the full text of this article appears below.


   Introduction
 
Contemporary clinical trails that show a beneficial effect on morbidity for a novel treatment often give an indeterminate result for mortality, which may be a component of a composite primary endpoint. Although a beneficial effect on a composite endpoint is often perceived by clinicians as indicating a beneficial effect on each of the components, this is often not the case. Typically, only one or two of the morbidity components are clearly demonstrated to benefit, with an indeterminate effect on mortality and the other morbidity components.

For example, consider a trial assessing the effect of a novel treatment for coronary artery disease on the composite endpoint of death or need for revascularization. A beneficial effect on this composite endpoint might be presented as a reduced risk of death . . . [Full Text of this Article]


   Interpretation of clinical trials with an indeterminate effect on mortality
 

   Summary
 

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