Health Affairs, 24, no. 1 (2005): 67-78 doi: 10.1377/hlthaff.24.1.67 © 2005 by Project HOPE	New Online   New Issue: China & India   Obesity In China   Pay Cuts For Medicare Docs   Access To Care Woes

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Surrogate Endpoints And FDA’s Accelerated Approval Process

View larger version (29K): [in a new window]   EXHIBIT 1 A Reason For The Unreliability Of A Proposed Surrogate Endpoint: The Proposed Surrogate Is Not In The Causal Pathway Of The Disease Process

View larger version (21K): [in a new window]   EXHIBIT 2 Additional Reasons For The Unreliability Of Proposed Surrogates: Disease Processes Having Multiple Causal Pathways And Interventions Having Mechanisms Of Action Independent Of The Disease Process

View larger version (20K): [in a new window]   EXHIBIT 3 Hazard Ratios For Disease-Free Survival (DFS) Versus Overall Survival (OS), Studies Of Adjuvant Colon Cancer, November 2003

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