Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study

Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study

Abstract Background The U.S. Food and Drug Administration (FDA) often approves new drugs based on trials that use surrogate markers for endpoints, which involve certain trade-offs and may risk making erroneous inferences about the medical product’s actual clinical effect. This study aims to compare...

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Bibliographic Details
Main Authors: Joshua D. Wallach, Oriana Ciani, Alison M. Pease, Gregg S. Gonsalves, Harlan M. Krumholz, Rod S. Taylor, Joseph S. Ross
Format: Article
Language:English
Published: BMC 2018-03-01
Series:BMC Medicine
Subjects:
Surrogate markers
Outcomes
Lifecycle evaluation
Regulation
U.S. Food and Drug Administration (FDA)
Online Access:http://link.springer.com/article/10.1186/s12916-018-1023-9

Internet

http://link.springer.com/article/10.1186/s12916-018-1023-9

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