Defining “Success” in recruitment of underrepresented populations to cancer clinical trials

Moving toward a more consistent approach

Authors

  • Shari Bolen M.D., M.P.H.,

    Corresponding author
    1. Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
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    • The authors of this article are responsible for its contents, including any clinical and treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human services.

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  • Jon Tilburt M.D., M.P.H.,

    1. Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
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    • The authors of this article are responsible for its contents, including any clinical and treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human services.

  • Charlie Baffi Ph.D., M.P.H.,

    1. Cancer Prevention Fellowship Program, National Cancer Institute, Bethesda, Maryland
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    • The authors of this article are responsible for its contents, including any clinical and treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human services.

  • Tiffany L. Gary Ph.D., M.H.S.,

    1. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
    2. Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland
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    • The authors of this article are responsible for its contents, including any clinical and treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human services.

  • Neil Powe M.D., M.P.H., M.B.A.,

    1. Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
    2. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
    3. Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland
    4. Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
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    • The authors of this article are responsible for its contents, including any clinical and treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human services.

  • Mollie Howerton Ph.D., M.P.H.,

    1. Cancer Prevention and Control, Johns Hopkins School of Medicine, Baltimore, Maryland
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    • The authors of this article are responsible for its contents, including any clinical and treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human services.

  • Jean Ford M.D.,

    1. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
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    • The authors of this article are responsible for its contents, including any clinical and treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human services.

  • Gabriel Lai M.H.S.,

    1. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
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    • The authors of this article are responsible for its contents, including any clinical and treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human services.

  • Renee Wilson M.S.,

    1. Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
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    • The authors of this article are responsible for its contents, including any clinical and treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human services.

  • Eric Bass M.D., M.P.H.

    1. Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
    2. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
    3. Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
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    • The authors of this article are responsible for its contents, including any clinical and treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human services.


  • This article is based on research conducted by Johns Hopkins Evidence Based Practice Center under contract 290-02-0018 to the Agency for Health Care Research and Quality, Rockville, MD.

Abstract

Although medically underserved groups bear a heavy burden of cancer disease and governmental agencies have required inclusion of minorities and women in cancer clinical trials since 1993, many of these groups are underrepresented in cancer prevention or treatment clinical trials. To assess and enhance recruitment of underrepresented populations into cancer-related clinical trials, investigators and governmental agencies need consistent measurement approaches for recruitment that can be applied to diverse settings where trials are conducted. We conducted a systematic review to evaluate what measurement approaches were used to evaluate the success of recruitment of underrepresented groups into cancer prevention or treatment trials, and whether these recruitment goals were stated a priori. Only two articles reported an a priori recruitment goal. The recruitment measurement approaches varied considerably, with no consistent standard, especially for individual trials. By using the empiric evidence from this review in conjunction with the National Institutes of Health (NIH) guidelines, we constructed a framework for choosing consistent a priori recruitment goals for underrepresented groups based on the research question and study location. Using consistent measurement approaches for underrepresented groups will improve comparability of recruitment strategies across trials, improve equity in distribution of benefits and burdens of cancer-related clinical trials, and may improve applicability of trial results to multiple populations. Cancer 2006. © 2006 American Cancer Society.

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