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Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study

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  • Andrew Schumacher
  • William M Sikov
  • Matthew I Quesenberry
  • Howard Safran
  • Humera Khurshid
  • Kristen M Mitchell
  • Adam J Olszewski

Abstract

Background: Informed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies. Methods: We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics. Results: Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P

Suggested Citation

  • Andrew Schumacher & William M Sikov & Matthew I Quesenberry & Howard Safran & Humera Khurshid & Kristen M Mitchell & Adam J Olszewski, 2017. "Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study," PLOS ONE, Public Library of Science, vol. 12(2), pages 1-13, February.
    • Handle: RePEc:plo:pone00:0172957
    DOI: 10.1371/journal.pone.0172957
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