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

  • Healthcare Policy and Outcomes
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

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.

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References

  1. Newman LA, Hurd T, Leitch M, Kuerer HM, Diehl K, Lucci A, et al. A report on accrual rates for elderly and minority-ethnicity cancer patients to clinical trials of the American College of Surgeons Oncology Group. J Am Coll Surg. 2004;199:644–51.

    Article  PubMed  Google Scholar 

  2. Newman LA, Lee CT, Parekh LP, Stewart AK, Thomas CR Jr, Beltran RA, et al. Use of the National Cancer Data Base to develop clinical trials accrual targets that are appropriate for minority ethnicity patients: a report from the American College of Surgeons Oncology Group (ACOSOG) Special Population Committee. Cancer. 2006;106:188–95.

    Article  PubMed  Google Scholar 

  3. NIH Revitalization Act. Public Law 103-43, 1993.

  4. Peterson ED, Lytle BL, Biswas MS, Coombs L. Willingness to participate in cardiac trials. Am J Geriatr Cardiol. 2004;13:11–5.

    Article  PubMed  Google Scholar 

  5. Beswick AD, Rees K, Griebsch I, Taylor FC, Burke M, West RR, et al. Provision, uptake and cost of cardiac rehabilitation programmes: improving services to under-represented groups. Health Technol Assess. 2004;8:iii–iv, ix–x, 1–152.

    Google Scholar 

  6. Bartlett C, Davey P, Dieppe P, Doyal L, Ebrahim S, Egger M. Women, older persons, and ethnic minorities: factors associated with their inclusion in randomised trials of statins 1990 to 2001. Heart. 2003;89:327–8.

    Article  PubMed  CAS  Google Scholar 

  7. Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med. 2002;162:1682–8.

    Article  PubMed  Google Scholar 

  8. Alvidrez J, Arean PA. Psychosocial treatment research with ethnic minority populations: ethical considerations in conducting clinical trials. Ethics Behav. 2002;12:103–16.

    Article  PubMed  CAS  Google Scholar 

  9. Miskimen T, Marin H, Escobar J. Psychopharmacological research ethics: special issues affecting US ethnic minorities. Psychopharmacology (Berl). 2003;171:98–104.

    Article  CAS  Google Scholar 

  10. Miranda J, Nakamura R, Bernal G. Including ethnic minorities in mental health intervention research: a practical approach to a long-standing problem. Cult Med Psychiatry. 2003;27:467–86.

    Article  PubMed  Google Scholar 

  11. Gifford AL, Cunningham WE, Heslin KC, Andersen RM, Nakazono T, Lieu DK, et al. Participation in research and access to experimental treatments by HIV-infected patients. N Engl J Med. 2002;346:1373–82.

    Article  PubMed  Google Scholar 

  12. Hussain-Gambles M, Atkin K, Leese B. Why ethnic minority groups are under-represented in clinical trials: a review of the literature. Health Soc Care Community. 2004;12:382–8.

    Article  PubMed  Google Scholar 

  13. Leffall LD Jr, Organ CH Jr. Honorary/Sandoz Nutrition Lectureship. Ethics in research and surgical practice. Am J Surg. 1997;174:589–91.

    Article  PubMed  Google Scholar 

  14. Leffall LD Jr. Ethics in surgical research. Surgery. 1998;123:603–5.

    Article  PubMed  Google Scholar 

  15. Betancourt JR. Cultural competence—marginal or mainstream movement? N Engl J Med. 2004;351:953–5.

    Article  PubMed  CAS  Google Scholar 

  16. Adams-Campbell LL, Ahaghotu C, Gaskins M, Dawkins FW, Smoot D, Polk OD, et al. Enrollment of African Americans onto clinical treatment trials: study design barriers. J Clin Oncol. 2004;22:730–4.

    Article  PubMed  Google Scholar 

  17. Simon MS, Du W, Flaherty L, Philip PA, Lorusso P, Miree C, et al. Factors associated with breast cancer clinical trials participation and enrollment at a large academic medical center. J Clin Oncol. 2004;22:2046–52.

    Article  PubMed  Google Scholar 

  18. Freeman HP, Muth BJ, Kerner JF. Expanding access to cancer screening and clinical follow-up among the medically underserved. Cancer Pract. 1995;3:19–30.

    PubMed  CAS  Google Scholar 

  19. Vargas RB, Ryan GW, Jackson CA, Rodriguez R, Freeman HP. Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. Cancer. 2008;113:426–33.

    Article  PubMed  Google Scholar 

  20. McGinnis LS, Menck HR, Eyre HJ, Bland KI, Scott-Conner CE, Morrow M, et al. National Cancer Data Base survey of breast cancer management for patients from low income zip codes. Cancer. 2000;88:933–45.

    Article  PubMed  CAS  Google Scholar 

  21. Stewart AK, Bland KI, McGinnis LS Jr, Morrow M, Eyre HJ. Clinical highlights from the National Cancer Data Base, 2000. CA Cancer J Clin. 2000;50:171–83.

    Article  PubMed  CAS  Google Scholar 

  22. Leitch AM, Beitsch PD, McCall LM, Posther K, Newman LA, Herndon JE II, et al. Patterns of participation and successful patient recruitment to American College of Surgeons Oncology Group Z0010, a phase II trial for patients with early-stage breast cancer. Am J Surg. 2005;190:539–42.

    Article  PubMed  Google Scholar 

  23. U.S. Census Bureau, Population Division, Population Projections Branch. Maintained by Information and Research Services Internet Staff (Population Division). http://www.census.gov/ipc/www/usinterimproj/ (March 18, 2004).

  24. McKinnon J. The black population in the United States: March 2002. Current Population Reports, Series P20-541. Washington, DC: U.S. Census Bureau; 2003.

  25. Ramirez RR, de La Cruz GP. The Hispanic population in the United States: March 2002. Current Population Reports, P20-545. Washington, DC: U.S. Census Bureau; 2002.

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Authors and Affiliations

  1. Department of Surgery and Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA

    Kathleen M. Diehl MD, FACS, Arden Morris MD, FACS & Lisa A. Newman MD, MPH, FACS

  2. Mayo Clinic, Rochester, MN, USA

    Erin M. Green & Heidi Nelson MD, FACS

  3. Baylor Medical College, Houston, TX, USA

    Armin Weinberg PhD

  4. Howard University, Washington, DC, USA

    Wayne A. Frederick MD, FACS

  5. Department of Breast Surgery, USC Norris Cancer Center, Los Angeles, CA, USA

    Dennis R. Holmes MD, FACS

  6. ACOSOG Patient Advocate Committee, c/o American College of Surgeons Oncology Group, Durham, NC, USA

    Bettye Green

  7. Department of Surgical Oncology, UTMD Anderson Cancer Center, Houston, TX, USA

    Henry M. Kuerer MD, PhD, FACS

  8. Latino Med Policy Institute, Los Alamitos, CA, USA

    Robert A. Beltran MD, MBA

  9. School of Medicine, Department of Surgery, Boston University, Boston, MA, USA

    Jane Mendez MD, FACS

  10. ACOSOG Special Populations Committee, c/o American College of Surgeons Oncology Group, Durham, NC, USA

    Venus Gines

  11. Department of Surgery, Duke University, Durham, NC, USA

    David M. Ota MD, FACS

Authors
  1. Kathleen M. Diehl MD, FACS
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  2. Erin M. Green
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  3. Armin Weinberg PhD
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  4. Wayne A. Frederick MD, FACS
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  5. Dennis R. Holmes MD, FACS
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  6. Bettye Green
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  7. Arden Morris MD, FACS
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  8. Henry M. Kuerer MD, PhD, FACS
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  9. Robert A. Beltran MD, MBA
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  10. Jane Mendez MD, FACS
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  11. Venus Gines
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  12. David M. Ota MD, FACS
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  13. Heidi Nelson MD, FACS
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  14. Lisa A. Newman MD, MPH, FACS
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Corresponding author

Correspondence to Lisa A. Newman MD, MPH, FACS.

Additional information

This study is conducted on behalf of the Special Populations Committee of the American College of Surgeons Oncology Group. We gratefully acknowledge the bravery and dedication of the cancer patients participating in our clinical trials.

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Diehl, K.M., Green, E.M., Weinberg, A. et al. Features Associated with Successful Recruitment of Diverse Patients onto Cancer Clinical Trials: Report from the American College of Surgeons Oncology Group. Ann Surg Oncol 18, 3544–3550 (2011). https://doi.org/10.1245/s10434-011-1818-9

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  • DOI: https://doi.org/10.1245/s10434-011-1818-9

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