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The Use of Surrogate Outcome Measures

A Case Study: Home Prothrombin Monitors
  • John J. Whyte

Abstract

One of the most important aspects of study design is the selection of outcome measures. The choice of the most appropriate primary and secondary outcome measures can be a complicated decision and represents one of the most complex issues in the design of a clinical trial. Appropriate outcome measures will determine both safety and clinical effectiveness, as well as potential reimbursement, based on the application of the rigorous evidence-based approach taken by the Centers for Medicare and Medicaid Services (CMS) and other payor/providers.1 Therefore, companies should devote considerable time to making certain the outcome measures chosen will be viewed as appropriate by reviewers and clinicians.

Keywords

Mechanical Heart Valve Hemorrhagic Event Surrogate Outcome Measure Complicated Decision Eventual Health Outcome 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Humana Press Inc. 2006

Authors and Affiliations

  • John J. Whyte
    • 1
  1. 1.Continuing Medical Education Discovery Health ChannelSilver Spring

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