The Use of Surrogate Outcome Measures
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.
KeywordsMechanical Heart Valve Hemorrhagic Event Surrogate Outcome Measure Complicated Decision Eventual Health Outcome
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