Association for Academic Surgery (AAS)

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How Inclusive are Referrals to Cancer Clinical Trials?

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There is a disparity in the survival of minority patients diagnosed with cancer. Although there is a higher incidence of cancer among Caucasians, there is higher mortality of these same diseases in African Americans (1).  Access to cancer screening and treatment may be at fault for this discrepancy in survival, but what about access to clinical trials in patients with end-stage cancer who are left with no other treatment options? There have been policy changes to increase representation of enrolled participants and research assessing the efficacy of such regulations, but there has not been a thorough evaluation of how patients are referred to or learn about clinical trials.

In an effort to increase the inclusion of more racial groups in clinical trials, Congress enacted the NIH Revitalization Act in 1993. This stipulated that clinical studies must disclose gender and race information of participants in order to receive federal funding (2).  In 2017, the NIH published guidelines stating that all NIH-funded clinical trials must include women and members of minority groups and their subpopulations (3). Despite these policy changes, enrollment of non-Caucasian participants in clinical trials has lagged, particularly in studies with industry sponsors.  A 2022 study found that in the past 20 years, less than half of 20,692 U.S. clinical trials disclosed race/ethnicity data and for those that did the majority of enrollees (median 79.7%) were Caucasian, which is incongruent with census estimates of the racial makeup of the general population (4).  There is evidence that eligibility criteria systematically exclude minorities from clinical trials (5). However, there is a paucity of data about the demographics of referred patients screened for eligibility.  It is unclear if the racial disparity is due to biased inclusion/exclusion criteria or lack of minority referrals to the clinical trials.

Modifications have been suggested to change inclusion/exclusion criteria of trials to allow for a more diverse group of patients to be eligible. Yet, there remains a lack of research about how patients get referred to clinical trials.  Patients searching for treatment options may have difficulties finding relevant experimental studies, especially if their primary oncologist is not well-versed in clinical trials.  Even if trial sponsors work to increase the inclusivity of their screening, this will not improve diversity if minority patients are never referred to these trials in the first place. How can clinical trials funded by both NIH and industry sponsors ensure that they are screening patients from all racial, ethnic, and socioeconomic backgrounds?  Ensuring an open line of communication between principal investigators and physicians in the community about clinical trial opportunities may increase referrals. However, more work needs to be done to spread information about clinical trials to all patients, especially minorities who may have less access to healthcare and are distrustful of the medical community.

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References

  1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33.
  2. Mutale F. Inclusion of Racial and Ethnic Minorities in Cancer Clinical Trials: 30 Years After the NIH Revitalization Act, Where Are We? J Adv Pract Oncol. 2022;13(8):755-7.
  3. NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research [Internet]. 2017. Available from: https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm.
  4. Turner BE, Steinberg JR, Weeks BT, Rodriguez F, Cullen MR. Race/ethnicity reporting and representation in US clinical trials: a cohort study. Lancet Reg Health Am. 2022;11.
  5. Riner AN, Girma S, Vudatha V, Mukhopadhyay N, Skoro N, Gal TS, et al. Eligibility Criteria Perpetuate Disparities in Enrollment and Participation of Black Patients in Pancreatic Cancer Clinical Trials. J Clin Oncol. 2022;40(20):2193-202.
Alexandra Gustafson, MD

Alexandra Gustafson, MD

Alexandra Gustafson, MD is a Surgery Branch/Cancer Immunotherapy Research Fellow at the National Cancer Institute. She graduated from Georgetown University Medical School and has completed two years of surgical residency at Metropolitan Hospital Center in New York City. She is interested in studying health care disparities within clinical trials. Twitter: @AlexGustafsonMD
Alexandra Gustafson, MD

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Mei Li Kwong

Mei Li Kwong

Mei Li M. Kwong, MD is an Assistant Research Physician and surgical oncologist in the Surgery Branch of the National Cancer Institute. She is the Associate Program Director for the Surgery Branch/Cancer Immunotherapy Research Fellowship that accepts three general surgery residents each year for 2-3 years of research training. Her research interests include adoptive cell therapy for the treatment of solid organ malignancies and working to improve DEI efforts in clinical trials. She is currently pursuing a flexible MBA from Johns Hopkins Carey Business School.
Mei Li Kwong

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About Alexandra Gustafson, MD

Alexandra Gustafson, MD is a Surgery Branch/Cancer Immunotherapy Research Fellow at the National Cancer Institute. She graduated from Georgetown University Medical School and has completed two years of surgical residency at Metropolitan Hospital Center in New York City. She is interested in studying health care disparities within clinical trials. Twitter: @AlexGustafsonMD