This Article  • References  • Full text PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Social Bookmarking   What's this?

Nick Freemantle, MA
Michael Drummond, DPhil University of York Heslington, York, United Kingdom

JAMA. 1997;277(21):1677.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

In Reply.

—We provided 2 examples of nonblinded real-world studies in our article, but we agree that it is artificial to consider a divide between real-world trials and those with high construct validity. Economic analyses require real-world estimates of effect (ie, what will be achieved), rather than the estimates of what can be achieved in the context of doubleblind phase 3 clinical trials. In phase 3 trials, artificial circumstances often may be required to ensure that the trial is estimating what the investigators hope to measure. It is more helpful to consider the degree to which the real world is lost in trials. We are describing a continuum rather than a dichotomy.

Standard phase 3 trials ask, "Will it work?" whereas an economic trial asks, "Is it worth doing?" These questions have different design implications, and it is rarely possible to answer both with high validity in the same trial. It may . . . [Full Text PDF of this Article]

Footnotes
Edited by Margaret A, Winker, MD, Senior Editor, and Phil B. Fontanarosa, MD, Senior Editor.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?