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Expectations of Benefit in Early-Phase Clinical Trials: Implications for Assessing the Adequacy of Informed Consent

Author

Listed:
  • Kevin P. Weinfurt

    (Center for Clinical and Genetic Economics, Duke Clinical Research Institute, kevin.weinfurt@duke.edu, Departments of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina)

  • Damon M. Seils

    (Center for Clinical and Genetic Economics, Duke Clinical Research Institute)

  • Janice P. Tzeng

    (Center for Clinical and Genetic Economics, Duke Clinical Research Institute)

  • Kate L. Compton

    (Center for Clinical and Genetic Economics, Duke Clinical Research Institute)

  • Daniel P. Sulmasy

    (The John J. Conley Department of Ethics, St. Vincents Manhattan, New York, New York, Bioethics Institute of New York Medical College, Valhalla, New York)

  • Alan B. Astrow

    (Maimonides Medical Center, Brooklyn, New York)

  • Nicholas A. Solarino

    (Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia, Pennsylvania)

  • Kevin A. Schulman

    (Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Departments of Psychiatry and Behavioral Sciences and Medicine, Duke University School of Medicine, Durham, North Carolina)

  • Neal J. Meropol

    (Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia, Pennsylvania)

Abstract

Background. Participants in early-phase clinical trials have reported high expectations of benefit from their participation. There is concern that participants misunderstand the trials to which they have consented, which is based on assumptions about what patients mean when responding to questions about likelihood of benefit. Methods. Participants were 27 women and 18 men in early-phase oncology trials at 2 academic medical centers in the United States. To determine whether expectations of benefit differ depending on how patients are queried, the authors randomly assigned participants to 1 of 3 interviews corresponding to 3 questions about likelihood of benefit: frequency type, belief type, and vague. In semistructured interviews, participants were queried about how they understood and answered the question. Participants then answered and discussed 1 of the other questions. Results. Expectations of benefit in response to the belief-type question were significantly greater than expectations in response to the frequency-type and vague questions ( P=0:02 ). The most common justifications involved positive attitude ( n=27 [60%]) and references to physical health ( n=23 [51%]). References to positive attitude were most common among participants with higher ( > 70%) expectations ( n = 11 [85%]) and least common among those with lower (

Suggested Citation

  • Kevin P. Weinfurt & Damon M. Seils & Janice P. Tzeng & Kate L. Compton & Daniel P. Sulmasy & Alan B. Astrow & Nicholas A. Solarino & Kevin A. Schulman & Neal J. Meropol, 2008. "Expectations of Benefit in Early-Phase Clinical Trials: Implications for Assessing the Adequacy of Informed Consent," Medical Decision Making, , vol. 28(4), pages 575-581, July.
    • Handle: RePEc:sae:medema:v:28:y:2008:i:4:p:575-581
    DOI: 10.1177/0272989X08315242
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    References listed on IDEAS

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    1. Henderson, Gail E. & Easter, Michele M. & Zimmer, Catherine & King, Nancy M.P. & Davis, Arlene M. & Rothschild, Barbra Bluestone & Churchill, Larry R. & Wilfond, Benjamin S. & Nelson, Daniel K., 2006. "Therapeutic misconception in early phase gene transfer trials," Social Science & Medicine, Elsevier, vol. 62(1), pages 239-253, January.
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