Annals of Surgical Oncology

, Volume 18, Issue 13, pp 3544–3550

Features Associated with Successful Recruitment of Diverse Patients onto Cancer Clinical Trials: Report from the American College of Surgeons Oncology Group

  • Kathleen M. Diehl
  • Erin M. Green
  • Armin Weinberg
  • Wayne A. Frederick
  • Dennis R. Holmes
  • Bettye Green
  • Arden Morris
  • Henry M. Kuerer
  • Robert A. Beltran
  • Jane Mendez
  • Venus Gines
  • David M. Ota
  • Heidi Nelson
  • Lisa A. Newman
Healthcare Policy and Outcomes

DOI: 10.1245/s10434-011-1818-9

Cite this article as:
Diehl, K.M., Green, E.M., Weinberg, A. et al. Ann Surg Oncol (2011) 18: 3544. doi:10.1245/s10434-011-1818-9

Abstract

Background

The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies.

Study Design

We evaluated the accrual patterns for 10 clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999–2009, and analyzed results by race/ethnicity as well as by study design.

Results

Eight of 10 protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully recruiting protocols were: (1) studies designed to recruit patients with regional or advanced-stage disease (2 of 2 protocols); and (2) studies that involved some investigational systemic therapy (3 of 3 protocols).

Discussion

AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients.

Copyright information

© Society of Surgical Oncology 2011

Authors and Affiliations

  • Kathleen M. Diehl
    • 1
  • Erin M. Green
    • 2
  • Armin Weinberg
    • 3
  • Wayne A. Frederick
    • 4
  • Dennis R. Holmes
    • 5
  • Bettye Green
    • 6
  • Arden Morris
    • 1
  • Henry M. Kuerer
    • 7
  • Robert A. Beltran
    • 8
  • Jane Mendez
    • 9
  • Venus Gines
    • 10
  • David M. Ota
    • 11
  • Heidi Nelson
    • 2
  • Lisa A. Newman
    • 1
  1. 1.Department of Surgery and Comprehensive Cancer CenterUniversity of MichiganAnn ArborUSA
  2. 2.Mayo ClinicRochesterUSA
  3. 3.Baylor Medical CollegeHoustonUSA
  4. 4.Howard UniversityWashingtonUSA
  5. 5.Department of Breast SurgeryUSC Norris Cancer CenterLos AngelesUSA
  6. 6.ACOSOG Patient Advocate CommitteeDurhamUSA
  7. 7.Department of Surgical OncologyUTMD Anderson Cancer CenterHoustonUSA
  8. 8.Latino Med Policy InstituteLos AlamitosUSA
  9. 9.School of Medicine, Department of SurgeryBoston UniversityBostonUSA
  10. 10.ACOSOG Special Populations CommitteeDurhamUSA
  11. 11.Department of SurgeryDuke UniversityDurhamUSA

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