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- Title
Inclusion of Comparative Effectiveness Data in High-Risk Cardiovascular Device Studies at the Time of Premarket Approval.
- Authors
Chen, Connie E.; Dhruva, Sanket S.; Redberg, Rita F.
- Abstract
The article discuses the study on high-risk cardiovascular device regarding the presence of comparative effectiveness data during the premarket approval of the devices by the approving agencies. It mentions the use of control data from previous report during the device trials, and highlights the importance of the test data of devices relating its selection bias and validity. It informs the methodology involving the extraction of data from the U.S. Food & Drug Administration (FDA) related to safety and effectiveness, and emphasis on the examination of the primary end points regarding the determination of type of controls used for the comparison of the device. INSET: Box. Coding of Studies and Primary End Points.
- Subjects
MEDICAL care research; MEDICAL equipment; CARDIOVASCULAR diseases; UNITED States. Food &; Drug Administration; PRODUCT safety; MEDICAL databases; MACHINERY safety; SYSTEM safety
- Publication
JAMA: Journal of the American Medical Association, 2012, Vol 308, Issue 17, p1740
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.2012.14491