Λεπτομέρειες βιβλιογραφικής εγγραφής
| Τίτλος: |
Price, performance, and the FDA approval process: the example of home HIV testing. |
| Συγγραφείς: |
Paltiel AD, Pollack HA |
| Πηγή: |
Medical Decision Making; Mar/Apr2010, Vol. 30 Issue 2, p217-223, 7p |
| Περίληψη: |
The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user POPULATION: The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process. [ABSTRACT FROM AUTHOR] |
|
Copyright of Medical Decision Making is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| Βάση Δεδομένων: |
Complementary Index |