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Participant Adherence

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Fundamentals of Clinical Trials

Abstract

The terms compliance and adherence are often used interchangeably. Compliance is defined as “the extent to which a person’s behavior (in terms of taking medications, following diets, or executing lifestyle changes) coincides with medical or health advice” [1]. The term adherence is defined similarly, but implies active participant involvement. This book uses the term adherence. For example, an adherer is a participant who meets the standards of adherence as established by the investigator. In a drug trial, he may be a participant who takes at least a predetermined amount such as 80% of the protocol dose. There should also be a maximum dose that defines adherence. This dose will depend on the nature of the drug being evaluated (no more than 100% for some, perhaps a bit higher for others). A review of 192 clinical trial publications from high-impact journals reveals important variability in the definition (and reporting) of medication adherence [2].

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Author information

Authors and Affiliations

  1. Bethesda, MD, USA

    Lawrence M. Friedman

  2. School of Medicine, Wake Forest University, Winston-Salem, NC, USA

    Curt D. Furberg

  3. Department of Biostatistics & Medical Informatics, University of Wisconsin, Madison, WI, USA

    David L. DeMets

Authors
  1. Lawrence M. Friedman
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  2. Curt D. Furberg
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  3. David L. DeMets
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Correspondence to Lawrence M. Friedman .

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© 2010 Springer New York

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Friedman, L.M., Furberg, C.D., DeMets, D.L. (2010). Participant Adherence. In: Fundamentals of Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-1586-3_14

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