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Clinical Evaluation of Medical Devices pp 41–58Cite as

Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devices

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Abstract

Deficiencies in recent medical device applications to the US Food and Drug Administration (FDA) have resulted in efforts to provide device manufacturers with guidelines for producing Premarket Approval Applications (PMAs) that contain scientific evidence for device safety and effectiveness.1 Traditionally, clinical trials are recommended by the FDA for evaluation of the safety and effectiveness of diagnostic and/or therapeutic interventions. Clinical trial methods include a statement of a hypothesis, definition of a target population group, identification of patient and intervention characteristics (independent variables), and well-defined objective outcome measures (dependent variables or endpoints). Outcome measures, then, are a key component in the materials that the FDA uses to review and assess the safety and effectiveness of new devices.

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Authors
  1. Selma A. Kunitz
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  2. Michele Gargano
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  3. Rene Kozloff
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Editors and Affiliations

  1. The Weinberg Group, Inc., Washington, DC, USA

    Karen Becker Witkin

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© 1998 Springer Science+Business Media New York

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Kunitz, S.A., Gargano, M., Kozloff, R. (1998). Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devices. In: Witkin, K.B. (eds) Clinical Evaluation of Medical Devices. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-4757-2756-2_3

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  • DOI: https://doi.org/10.1007/978-1-4757-2756-2_3

  • Publisher Name: Humana Press, Totowa, NJ

  • Print ISBN: 978-1-61737-040-3

  • Online ISBN: 978-1-4757-2756-2

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