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Clinical Trials: Not for the Poor and the Old

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Cancer and Society

Abstract

The oncology clinical trial enterprise relies on the voluntary participation of cancer patients. The percentage of adults with cancer enrolled in clinical trials is extremely small and primarily consists of White, insured patients who are less than 65 years of age. Low accrual causes delays and termination of many trials. Skewed study populations result in data that is not generalizable to poor and elderly patients. Inequitable access to oncology clinical trials harms current and future cancer patients. Correcting this inequity is a matter of patient safety and justice. This chapter will review participation rates, factors related to accrual, and potential areas for improvement.

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References

  1. Abola MV, Prasad V. The use of superlatives in cancer research. JAMA Oncol. 2016;2:139–41. https://doi.org/10.1001/jamaoncol.2015.3931.

    Article  Google Scholar 

  2. Advani AS, et al. Barriers to the participation of African-American patients with cancer in clinical trials: a pilot study. Cancer. 2003;97:1499–506.

    Article  Google Scholar 

  3. ASCO. The state of cancer care in America, 2017: a report by the American Society of Clinical Oncology. J Oncol Pract. 2017;13:e353–94. https://doi.org/10.1200/jop.2016.020743.

    Article  Google Scholar 

  4. ASPE. U.S. Federal Poverty guidelines used to determine financial eligibility for certain federal programs. 2018. https://aspe.hhs.gov/poverty-guidelines.

  5. Baik CS, et al. Immuno-oncology clinical trial design: limitations, challenges, and opportunities. Clin Cancer Res. 2017;23:4992–5002. https://doi.org/10.1158/1078-0432.ccr-16-3066.

    Article  Google Scholar 

  6. Bennette CS, Ramsey SD, McDermott CL, Carlson JJ, Basu A, Veenstra DL. Predicting low accrual in the National Cancer Institute’s Cooperative Group Clinical Trials JNCI. J Natl Cancer Inst. 2016;108:djv324. https://doi.org/10.1093/jnci/djv324.

    Article  Google Scholar 

  7. Bui Q, Sanger-Katz M. We mapped the uninsured. You’ll notice a pattern. 2015. https://www.nytimes.com/interactive/2015/10/31/upshot/who-still-doesnt-have-health-insurance-obamacare.html.

  8. Carrieri D, Peccatori FA, Boniolo G. The ethical plausibility of the ‘Right To Try’ laws. Crit Rev Oncol Hematol. 2018;122:64–71.

    Article  CAS  Google Scholar 

  9. Center for Disease Control. National Center for Health Statistics FastStats: Centers for Disease Control and Prevention; 2017. https://www.cdc.gov/nchs/fastats/cancer.htm.

  10. Census.gov. FFF: Older Americans month: May 2017 – Census.gov. 2017. https://www.census.gov/content/dam/Census/newsroom/facts-for-features/2017/cb17-ff08.pdf.

  11. Cherubini A, Signore SD, Ouslander J, Semla T, Michel JP. Fighting against age discrimination in clinical trials. J Am Geriatr Soc. 2010;58:1791–6. https://doi.org/10.1111/j.1532-5415.2010.03032.x.

    Article  Google Scholar 

  12. Clinicaltrials.gov. https://clinicaltrials.gov/ct2/results/map/click?recrs=a&type=Intr&cond=Breast+Cancer&cntry=US&age=12&phase=01234&mapw=1726&map.x=352&map.y=359. Accessed 4 June 2018.

  13. Comarow A. FAQ: how and why we rank and rate hospitals. U.S. News & World Report. 2017. https://health.usnews.com/health-care/best-hospitals/articles/faq-how-and-why-we-rank-and-rate-hospitals. Accessed 14 June 2018.

  14. DHEW. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. 1979. https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf.

  15. Duma N, et al. Representation of minorities and women in oncology clinical trials: review of the past 14 years. J Oncol Pract. 2018;14:e1–e10. https://doi.org/10.1200/jop.2017.025288.

    Article  Google Scholar 

  16. Elliott C. The anatomy of research scandals the Hastings Center Report 47:inside. 2017. https://doi.org/10.1002/hast.704.

    Google Scholar 

  17. Faden R, Kass N, Goodman S, Pronovost P, Tunis S, Beauchamp T. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep. 2013;43:S16–27. https://doi.org/10.1002/hast.134.

    Article  Google Scholar 

  18. Fayed L. Review of cost coverage for participating in a clinical trial. https://www.verywellhealth.com/are-clinical-trials-free-513637. Accessed 14 June 2018.

  19. FDA 21 CFR 21 Part 56 Institutional Review Boards.

    Google Scholar 

  20. FDA 21 CFR 56.111 Criteria for IRB approval of research.

    Google Scholar 

  21. FDA. Guidance for industry: E9 statistical principles for clinical trials. 1998. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073137.pdf.

  22. FDA. 2004. IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071717.pdf.

  23. FDA. 2014. FDA action plan to enhance the collection and availability of demographic subgroup data. https://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf.

  24. Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375:454–63. https://doi.org/10.1056/NEJMra1510059.

    Article  Google Scholar 

  25. Freedman RA, et al. Promoting accrual of older patients with cancer to clinical trials: an alliance for clinical trials in oncology member survey (A171602). Oncologist. 2018;23:1016. https://doi.org/10.1634/theoncologist.2018-0033.

    Article  Google Scholar 

  26. Garcia S, et al. Thoracic oncology clinical trial eligibility criteria and requirements continue to increase in number and complexity. J Thorac Oncol. 2017;12:1489–95. https://doi.org/10.1016/j.jtho.2017.07.020.

    Article  Google Scholar 

  27. Gerber DE, Lakoduk AM, Priddy LL, Yan J, Xie X-J. Temporal trends and predictors for cancer clinical trial availability for medically underserved populations. Oncologist. 2015;20:674–82. https://doi.org/10.1634/theoncologist.2015-0083.

    Article  Google Scholar 

  28. Grady C. Payment of clinical research subjects. J Clin Invest. 2005;115:1681–7. https://doi.org/10.1172/JCI25694.

    Article  CAS  Google Scholar 

  29. Gross CP, Krumholz HM, Van Wye G, Emanuel EJ, Wendler D. Does random treatment assignment cause harm to research participants? PLoS Med. 2006;3:e188.

    Article  Google Scholar 

  30. Height DI. The need for justice in human participants research: life after the Belmont Commission. J Cancer Educ. 2009;24:S19. https://doi.org/10.1080/08858190903400401.

    Article  Google Scholar 

  31. J. L. Semega, KR Fontenot, M.A. Kollar. Income and poverty in the United States: 2016 current population reports. 2017.

    Google Scholar 

  32. Jadhav S. Are clinical trial matching services truly patient-centric?. 2017. http://www.appliedclinicaltrialsonline.com/print/327315?page=full. Accessed 18 June 2018.

  33. Jin S, Pazdur R, Sridhara R. Re-evaluating eligibility criteria for oncology clinical trials: analysis of investigational new drug applications in 2015. J Clin Oncol. 2017;35:3745–52. https://doi.org/10.1200/jco.2017.73.4186.

    Article  CAS  Google Scholar 

  34. Joffe S, Weeks JC. Views of American oncologists about the purposes of clinical trials. J Natl Cancer Inst. 2002;94:1847–53. https://doi.org/10.1093/jnci/94.24.1847.

    Article  Google Scholar 

  35. Johnson RG, Dornsife DL. Equitable access to cancer clinical trials: erasing the stigma of undue inducement. Oct 23, 2017. ASCO Connection. https://connection.asco.org/magazine/features/equitable-accesscancer-clinical-trials-erasing-stigma-undue-inducement.

  36. Krohn T. Patient centricity in clinical trials: when searching is a struggle antidote. 2018. https://www.acrpnet.org/2018/01/17/patient-centricity-clinical-trials-searching-struggle/. Accessed 18 June 2018.

  37. Lichtman SM, Hurria A, Jacobsen PB. Geriatric oncology: an overview. J Clin Oncol. 2014;32:2521–2. https://doi.org/10.1200/jco.2014.57.4822.

    Article  Google Scholar 

  38. London A, Kimmelman J. Clinical trials in medical center advertising. JAMA Oncol. 2018;4:769. https://doi.org/10.1001/jamaoncol.2018.0181.

    Article  Google Scholar 

  39. Manne S, et al. Attitudinal barriers to participation in oncology clinical trials: factor analysis and correlates of barriers. Eur J Cancer Care. 2015;24:28–38. https://doi.org/10.1111/ecc.12180.

    Article  CAS  Google Scholar 

  40. Menikoff J, Kaneshiro J, Pritchard I. The common rule, updated. N Engl J Med. 2017;376:613–5. https://doi.org/10.1056/NEJMp1700736.

    Article  Google Scholar 

  41. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291:2720–6. https://doi.org/10.1001/jama.291.22.2720.

    Article  CAS  Google Scholar 

  42. Narang AK, Nicholas L. Out-of-pocket spending and financial burden among medicare beneficiaries with cancer. JAMA Oncol. 2017;3:757–65. https://doi.org/10.1001/jamaoncol.2016.4865.

    Article  Google Scholar 

  43. Nijjar S, D’Amico M, Wimalaweera N, Cooper N, Zamora J, Khan K. Participation in clinical trials improves outcomes in women’s health: a systematic review and meta-analysis. BJOG. 2018;124:863–71. https://doi.org/10.1111/1471-0528.14528.. @10.1002/(ISSN)1471-0528(CAT)EditorsPick(VI)EditorsPick.

    Article  Google Scholar 

  44. Nipp RD, et al. Financial burden of cancer clinical trial participation and the impact of a cancer care equity program. Oncologist. 2016;21:467–74. https://doi.org/10.1634/theoncologist.2015-0481.

    Article  CAS  Google Scholar 

  45. Right to Try Movement. 2018. http://righttotry.org/. Accessed 13 June 2018.

  46. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67:7–30. https://doi.org/10.3322/caac.21387.

    Article  Google Scholar 

  47. Singh GK, Jemal A. Socioeconomic and racial/ethnic disparities in cancer mortality, incidence, and survival in the United States, 1950-2014: over six decades of changing patterns and widening inequalities. J Environ Public Health. 2017;2017:2819372. https://doi.org/10.1155/2017/2819372.

    Article  Google Scholar 

  48. Strauss DC, Thomas JM. What does the medical profession mean by “Standard of Care?”. J Clin Oncol. 2009;27:e192–3. https://doi.org/10.1200/jco.2009.24.6678.

    Article  Google Scholar 

  49. Townsley CA, Selby R, Siu LL. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol. 2005;23:3112–24. https://doi.org/10.1200/jco.2005.00.141.

    Article  Google Scholar 

  50. Unger JM, Gralow JR, Albain KS, Ramsey SD, Hershman DL. Patient income level and cancer clinical trial participation: a prospective survey study. JAMA Oncol. 2016;2:137–9. https://doi.org/10.1001/jamaoncol.2015.3924.

    Article  Google Scholar 

  51. Wallach JD, Ross JS, Naci H. The US Food and Drug Administration’s expedited approval programs: evidentiary standards, regulatory trade-offs, and potential improvements. Clin Trials. 2018;15:219–29. https://doi.org/10.1177/1740774518770648.

    Article  Google Scholar 

  52. Weber JS, et al. American Society of Clinical Oncology policy statement update: the critical role of phase I trials in cancer research and treatment. J Clin Oncol. 2015;33:278–84. https://doi.org/10.1200/jco.2014.58.2635.

    Article  Google Scholar 

  53. Wong Y-N, et al. Financial concerns about participation in clinical trials among patients with cancer. J Clin Oncol. 2016;34:479–87. https://doi.org/10.1200/jco.2015.63.2463.

    Article  CAS  Google Scholar 

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Correspondence to Mary K. Clancy .

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Clancy, M.K. (2019). Clinical Trials: Not for the Poor and the Old. In: Bernicker, E. (eds) Cancer and Society. Springer, Cham. https://doi.org/10.1007/978-3-030-05855-5_5

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  • DOI: https://doi.org/10.1007/978-3-030-05855-5_5

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