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Understanding Verbosity: Funding Source and the Length of Consent Forms for Cancer Clinical Trials

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Abstract

Consent forms are an important educational tool that helps cancer patients decide on whether or not to enroll on a clinical trial, but wordiness potentially detracts from their educational value. This single-institution study examined word counts of consent forms for all phase I, II, and III solid tumor clinical trials between 2004 and 2010. Consent forms were categorized by trial funding source: (1) pharmaceutical company; (2) National Clinical Trials Network (NCTN); (3) R01- or other non-government grants; and (4) mixed (funding from multiple sources). Three hundred fifteen consent forms were studied; these included 106 (34%) pharmaceutical company; 145 (46%) NCTN; 44 (14%) R01 type; and 20 (6%) mixed. The overall median word count was 5129 words per consent form (interquartile range (IQR) range, 4226 to 6695). The median word counts per consent form (IQR) were 5648 (4814, 6803), 5243 (4139, 6932), 4365 (3806, 5124), and 4319 (3862, 5944), respectively, based on the above funding sources, showing that pharmaceutical company trial consent forms had the highest median word count. Of note, phase of trial was associated with consent form length (phase III were wordier), and consent forms manifested a consistent increase in wordiness over time. These observations underscore a timely need to find ways to limit the verbosity of consent forms, particularly in those from pharmaceutical company trials.

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Funding

This work was supported in part by K12CA090628 and by P30CA15083.

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Authors and Affiliations

  1. Section of Cancer Center Biostatistics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA

    Quyen Duong, Sumithra J. Mandrekar & Jennifer G. Le-Rademacher

  2. Section of Computational Genomics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA

    Stacey J. Winham

  3. Department of Oncology, Mayo Clinic, Rochester, MN, USA

    Kathryn Cook & Aminah Jatoi

  4. Betty J. Foust, M.D. and Parents’ Professor, 200 First Street SW, Rochester, MN, 55905, USA

    Aminah Jatoi

Authors
  1. Quyen Duong
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  2. Sumithra J. Mandrekar
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  3. Stacey J. Winham
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  4. Kathryn Cook
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  5. Aminah Jatoi
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  6. Jennifer G. Le-Rademacher
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Correspondence to Aminah Jatoi.

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Duong, Q., Mandrekar, S.J., Winham, S.J. et al. Understanding Verbosity: Funding Source and the Length of Consent Forms for Cancer Clinical Trials. J Canc Educ 36, 1248–1252 (2021). https://doi.org/10.1007/s13187-020-01757-7

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  • DOI: https://doi.org/10.1007/s13187-020-01757-7

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