Background: Enrollment rates for cancer clinical trials, estimated to be as low as 8% nationally with significant variability based on patient demographics, have been an ongoing barrier to scientific advances in oncology care.1 Specifically, the FDA noted an underrepresentation of people from racial and ethnic minority groups (REMGs) in clinical research,2 with a recent analysis showing only 2% of the 10,000 National Cancer Institute–funded trials adequately represented minority patients.3 The FDA also identifies the lack of children and adolescents included in clinical trials compared with adults and made recommendations to increase this population in future trials.4 Despite this recommendation, there has been a recent decline in clinical trial participation in pediatrics from 40%-70% to 19.9%.5 Utilization of patient navigators has been found to be among the most effective institutional approaches for recruiting REMGs and underserved participants to clinical trials6; however, the impact of a nationally based clinical trial nurse navigation program on trial enrollment in underserved populations has yet to be explored.
Objectives: To determine the impact of the Leukemia & Lymphoma Society’s (LLS’s) Clinical Trial Support Center (CTSC) nurse navigation services on clinical trial enrollment for underserved patients with hematologic malignancies across the age spectrum.
Methods: Composed of highly trained advanced practice nurses and registered nurses, the CTSC delivers a personalized, patient-centered navigation service to provide patients with clinical trials while addressing barriers to enrollment and providing education. The CTSC nurses provide an individualized list of appropriate trials based on the patient’s preferences, medical history, insurance, travel capability, and financial barriers. Deidentified, quantitative data from 812 adult and pediatric patients served by the CTSC during 2019 and 2020 were analyzed. For the purposes of this study, race and ethnicity were self-identified: non-Hispanic white (n = 625); 2 or more races (n = 3); prefer not to disclose (n = 57); REMGs included Hispanic/Latino (n = 54); American Indian/Native Alaskan (n = 2); black/African American (n = 51); Asian (n = 19); Native Hawaiian/Pacific Islander (n = 1).
Results: Sixteen percent (n = 130/812) of patients who requested a trial search by the CTSC in 2019 and 2020 enrolled in a clinical trial. Of those served by the CTSC, those self-identifying with an REMG comprised 16% (n = 130/812), with the majority identifying as black/African American (n = 58), Hispanic (n = 54), or a combination of REMG. The rate of enrollment was similar between those who identified as REMG (15%, n = 20/130) and the enrollment rate of patients who identified as non-Hispanic white (16%, n = 102/625). Pediatric patients aged <18 years had an enrollment rate of 27% (n = 7/26), 7 patients in the pediatric group self-identified as a member of the REMG, of which 14% (n = 1/7) enrolled.
Conclusions: Use of a nationally focused, clinical trial nurse navigation program for hematologic malignancies facilitated trial enrollment rates above the national average with 16% overall, 15% in REMG, and 27% in pediatrics. LLS recognizes increased efforts are needed to improve the reach to additional REMG and pediatric patients by implementing programs, services, and research to meet this need.
- American Cancer Society Cancer Action Network. Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer – A Landscape Report 2018. www.fightcancer.org/policy-resources/clinical-trial-barriers. 2018.
- US Food and Drug Administration. Clinical Trial Diversity. US Department of Health and Human Services. www.fda.gov/media/106965/down load. 2021.
- Virgil H. Understanding the Impact of Racial Representation on Clinical Cancer Trials. OncLive. www.onclive.com/view/understanding-the-im pact-of-racial-representation-on-clinical-cancer-trials. 2020.
- US Department of Health and Human Services. Food and Drug Administration. Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry. www.fda.gov/media/127712/download. 2020.
- Faulk KE, Anderson-Mellies A, Cockburn M, Green AL. Assessment of enrollment characteristics for Children’s Oncology Group (COG) upfront therapeutic clinical trials 2004-2015. Plos One. 2020;15:e0230824.
- Cook ED, Yeager KA, Cecchini RS, et al. Recruitment practices for U.S. minority and underserved populations in NRG oncology: results of an online survey. Contemp Clin Trials Commun. 2918;10:100-104.