Abstract
Purpose of Review
Cancer clinical trials remain highly underrepresented from racial and ethnic minorities. The lack of diversity in clinical trials significantly impacts the generalizability of drug treatments approved for cancer patients. This review intends to discuss recent shifts in cancer clinical trials to increase equitable participation across all patient populations.
Recent Findings
Current trends highlight innovative ways to build accessible clinical trials with diverse patient populations in mind. Patient-driven technology in the form of digital health platforms was created to address the gap in financial and non-financial barriers to clinical trial participation.
Summary
Recent research sheds light on ways to make clinical trials more accessible to patients. This review will showcase how clinical trial site leaders, coordinators, and sponsors can meet the needs of patients to ensure they can participate in future clinical trials by engaging with community leaders and patient organizations.
Similar content being viewed by others
References
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
Newman LA, Roff NK, Weinberg AD. Cancer clinical trials accrual: missed opportunities to address disparities and missed opportunities to improve outcomes for all. Ann Surg Oncol. 2008;15:1818–9.
Clark LT, Watkins L, Piña IL, Elmer M, Akinboboye O, Gorham M, et al. Increasing diversity in clinical trials: overcoming critical barriers. Curr Probl Cardiol. 2019;44:148–72.
Borno HT, Zhang L, Siegel A, Chang E, Ryan CJ. At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical trials. Oncologist. 2018;23:1242–9.
Sharrocks K, Spicer J, Camidge DR, Papa S. The impact of socioeconomic status on access to cancer clinical trials. Br J Cancer. 2014;111:1684–7.
Ford JG, Howerton MW, Lai GY, Gary TL, Bolen S, Gibbons MC, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer. 2008;112:228–42.
•• Corkum J, Zhu V, Agbafe V, Sun SX, Chu C, Colen JS, et al. Area deprivation index and rurality in relation to financial toxicity among breast cancer surgical patients: retrospective cross-sectional study of geospatial differences in risk profiles. J Am Coll Surg. 2022;234:816. This paper reveals how one’s geographical location, particularly in rural areas, plays a role in experiencing financial toxicity when diagnosed with breast cancer. The scholars found that by living in rural areas, there is a greater risk of being confronted with financial toxicity. This study can inform how community-based interventions can be integrated within the cancer care continuum.
• Offodile AC, Asaad M, Boukovalas S, Bailey C, Lin Y-L, Teshome M, et al. Financial toxicity following surgical treatment for breast cancer: a cross-sectional pilot study. Ann Surg Oncol. 2021;28:2451–62. (The scholars in this pilot study found financial toxicity is a major stressor among breast cancer patients undergoing surgical treatment. This is significant because if medical providers are knowledgeable of this earlier in the continuum of care, financial navigation can positively impact the patient’s journey and reduce stressors.)
•• Williams AD, Moo T-A. The impact of socioeconomic status and social determinants of health on disparities in breast cancer incidence, treatment, and outcomes. Curr Breast Cancer Rep. 2023;15:30–6. (This review illustrates the connections between economic status and social determinants of health in breast cancer. The authors emphasize that one’s community and their ties (e.g., social networks) can impact their trajectories; this should be taken into account across all healthcare settings.)
• Rivera-Díaz M, García-Romero AN, Ayala-Marín AM, Vélez-Alamo C, Acevedo-Fontánez AI, Arévalo M, et al. Knowledge, Motivations and concerns about participation in breast cancer clinical trials in Puerto Rico. J Health Disparities Res Pract. 2020;13:50–66. (This study focused on Latina breast cancer survivors and their experiences and understandings of cancer clinical trials. The authors found there are numerous issues surrounding trust concerns of site coordinators and the difficulties of participating in clinical trials for short and long periods of time.)
Trant AA, Walz L, Allen W, DeJesus J, Hatzis C, Silber A. Increasing accrual of minority patients in breast cancer clinical trials. Breast Cancer Res Treat. 2020;184:499–505.
Occa A, Morgan SE, Potter JE. Underrepresentation of Hispanics and other minorities in clinical trials: recruiters’ perspectives. J Racial Ethn Health Disparities. 2018;5:322–32.
Winter SS, Page-Reeves JM, Page KA, Haozous E, Solares A, Nicole Cordova C, et al. Inclusion of special populations in clinical research: important considerations and guidelines. J Clin Transl Res. 2018;4:56–69.
• He Z, Tang X, Yang X, Guo Y, George TJ, Charness N, et al. Clinical trial generalizability assessment in the big data era: a review. Clin Transl Sci. 2020;13:675–84. (This paper reviewed clinical trials and data generalizability, and its implications in real-world data. The scholars underscore how participants in clinical trial studies must be reflexive of the target patient population the drug is intended for.)
Unger JM, Cook E, Tai E, Bleyer A. Role of clinical trial participation in cancer research: barriers, evidence, and strategies. Am Soc Clin Oncol Educ Book. 2016;35:185–98.
• Saini G, Gogineni K, Kittles RA, Aneja R. Undercutting efforts of precision medicine: roadblocks to minority representation in breast cancer clinical trials. Breast Cancer Res Treat. 2021;187:605–11. (This paper discussed the challenges to increase Black women’s participation in clinical trials. The authors found proximity to trial sites and enrollment requirements were some of the reasons why Black women were not able to participate in clinical trial studies.)
Jiagge E, Chitale D, Newman LA. Triple-negative breast cancer, stem cells, and African ancestry. Am J Pathol. 2018;188:271–9.
Martini R, Delpe P, Chu TR, Arora K, Lord B, Verma A, et al. African ancestry-associated gene expression profiles in triple-negative breast cancer underlie altered tumor biology and clinical outcome in women of african descent. Cancer Discov. 2022;12:2530–51.
Hamel LM, Penner LA, Albrecht TL, Heath E, Gwede CK, Eggly S. Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer. Cancer Control. 2016;23:327–37.
Zafar SY, Abernethy AP. Financial toxicity, part I: a new name for a growing problem. Oncology (Williston Park). 2013;27:80–149.
Pangestu S, Rencz F. Comprehensive score for financial toxicity and health-related quality of life in patients with cancer and survivors: a systematic review and meta-analysis. Value Health. 2023;26:300–16.
Carrera PM, Kantarjian HM, Blinder VS. The financial burden and distress of patients with cancer: understanding and stepping-up action on the financial toxicity of cancer treatment. CA Cancer J Clin. 2018;68:153–65.
Gordon LG, Merollini KMD, Lowe A, Chan RJ. A systematic review of financial toxicity among cancer survivors: we can’t pay the co-pay. Patient. 2017;10:295–309.
Keese M. Who feels constrained by high debt burdens? Subjective vs. objective measures of household debt. J Econ Psychol. 2012;33:125–41.
Meeker CR, Geynisman DM, Egleston BL, Hall MJ, Mechanic KY, Bilusic M, et al. Relationships among financial distress, emotional distress, and overall distress in insured patients with cancer. J Oncol Pract. 2016;12:e755–64.
Corbie-Smith G, Thomas SB, St. George DMM. Distrust, race, and research. Arch Intern Med. 2002;162:2458–63.
Scharff DP, Mathews KJ, Jackson P, Hoffsuemmer J, Martin E, Edwards D. More than Tuskegee: understanding mistrust about research participation. J Health Care Poor Underserved. 2010;21:879–97.
Ling AY, Montez-Rath ME, Carita P, Chandross KJ, Lucats L, Meng Z, et al. An overview of current methods for real-world applications to generalize or transport clinical trial findings to target populations of interest. Epidemiology. 2023;34:627–36.
Whyte J, Woodcock J, Wang J. Review of the drug trials snapshots program of the US food and drug administration. JAMA Intern Med. 2017;177:724–7.
FDA. Enhancing the diversity of clinical trial populations — eligibility criteria, enrollment practices, and trial designs guidance for industry. 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial. Accessed 30 Aug 2023
Loree JM, Anand S, Dasari A, Unger JM, Gothwal A, Ellis LM, et al. Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018. JAMA Oncol. 2019;5:e191870.
Breastcancer.org. Special report: increasing racial diversity in breast cancer clinical trials. https://www.breastcancer.org/treatment/clinical-trials/diversity-in-trials. Accessed 6 Sep 2023
Reid S, Kennedy L, Mayer I, Pal T. Addressing racial disparities in breast cancer clinical trial enrollment [Internet]. ASCO Dly. News. https://doi.org/10.1200/ADN.21.200499/full
Frey W. The US will become “minority white” in 2045, Census projects. Brookings. 2018. https://www.brookings.edu/articles/the-us-will-become-minority-white-in-2045-census-projects/. Accessed 30 August 2023
ASCO in Action. 47 states have implemented the CLINICAL TREATMENT Act, increasing access to cancer clinical trials. ASCO. 2023. https://old-prod.asco.org/news-initiatives/policy-news-analysis/47-states-have-implemented-clinical-treatment-act-increasing. Accessed 6 Sep 2023
Leach V, Balogun O, Davis M, Warner E, Sutton A, Kalu O, et al. The importance of enrolling diverse populations in clinical trials. RACE ALLIANCE. 2022. https://www.tigerlilyfoundation.org/race-alliance/. Accessed 11 Sep 2023
Moore M. FDA issues new draft guidance to promote diversity in clinical trials. Oncol Pract Manag. 2022;12:19–19.
Regnante JM, Fashoyin-Aje L, Sonet EM, Highsmith Q, Gonzales M, Amaro S, et al. Abstract PO-084: the pharmaceutical industry in action: 2021 clinical research diversity and inclusion survey. Cancer Epidemiol Biomarkers Prev. 2022;31:084. https://doi.org/10.1158/1538-7755.DISP21-PO-084.
Dy T, Hamilton WJ, Kramer CB, Apter A, Krishnan JA, Stout JW, et al. Stakeholder engagement in eight comparative effectiveness trials in African Americans and Latinos with asthma. Res Involv Engagem. 2022;8:1–16.
Tigerlily Foundation. Young women’s advocate now to grow, empower and lead (ANGEL) advocacy training [Internet]. https://www.tigerlilyfoundation.org. 2021. https://www.tigerlilyfoundation.org/programs/angel/. Accessed 6 Sep 2023.
Fair market calculator [Internet]. Natl. Health Counc. https://nationalhealthcouncil.org/fair-market-value-calculator/. Accessed 30 Aug 2023.
Wells KJ, Valverde P, Ustjanauskas AE, Calhoun EA, Risendal BC. What are patient navigators doing, for whom, and where? A national survey evaluating the types of services provided by patient navigators. Patient Educ Couns. 2018;101:285–94.
Mollica MA, Nemeth LS, Newman SD, Mueller M, Sterba K. Peer navigation in African American breast cancer survivors. Patient Relat Outcome Meas. 2014;5:131–44.
Vicini F, Nancarrow-Tull J, Shah C, Chmielewski G, Fakhouri M, Sitarek SA, et al. Increasing accrual in cancer clinical trials with a focus on minority enrollment. Cancer. 2011;117:4764–71.
Connors SK, Leal IM, Nitturi V, Iwundu CN, Maza V, Reyes S, et al. Empowered choices: African-American women’s breast reconstruction decisions. Am J Health Behav. 2021;45:352–70.
Ashing-Giwa K, Tapp C, Rosales M, McDowell K, Martin V, Santifer RH, et al. Peer-based models of supportive care: the impact of peer support groups in African American breast cancer survivors. Oncol Nurs Forum. 2012;39:585–91.
Wells KJ, Wightman P, Aguilar RC, Dwyer AJ, Garcia-Alcaraz C, Ferrer ELS, et al. Comparing clinical and non-clinical cancer patient navigators: a national study in the United States. Cancer. 2022;128:2601–9.
Nolan TS, Ivankova N, Carson TL, Spaulding A, Davies S, Enah C, et al. Perceptions of a breast cancer survivorship intervention: pearls of wisdom from young African American women. J Adolesc Young Adult Oncol. 2019;8:165–71.
Pratt-Chapman M, Simon MA, Patterson AK, Risendal BC, Patierno S. Survivorship navigation outcome measures: a report from the ACS patient navigation working group on survivorship navigation. Cancer. 2011;117:3575–84.
• Niranjan SJ, Martin MY, Fouad MN, Vickers SM, Wenzel JA, Cook ED, et al. Bias and stereotyping among research and clinical professionals: perspectives on minority recruitment for oncology clinical trials. Cancer. 2020;126:1958–68. (This qualitative study aimed to investigate how different stakeholder groups view clinical trial participants. The authors found that cancer center leaders, principal investigators, referring clinicians, and research staff did not view racial and ethnic minority patients as ideal clinical trial participants for various reasons.)
Davis CM, Myers HF, Nyamathi AM, Lewis M, Brecht M-L. The meaning of survivorship as defined by African American breast cancer survivors. J Transcult Nurs. 2016;27:277–85.
Nouvini R, Parker PA, Malling CD, Godwin K, Costas-Muñiz R. Interventions to increase racial and ethnic minority accrual into cancer clinical trials: a systematic review. Cancer. 2022;128:3860–9.
Bernardo BM, Zhang X, Beverly Hery CM, Meadows RJ, Paskett ED. The efficacy and cost-effectiveness of patient navigation programs across the cancer continuum: a systematic review. Cancer. 2019;125:2747–61.
Tigerlily Foundation. RAISE | Resources and assistance for support and empowerment – powered by WiTT – we’re in this together. https://raise.tigerlilyfoundation.org/. Accessed 10 Sep 2023
Lazarex Cancer Foundation. Lazarex Care - Lazarex Cancer Foundation. https://lazarex.org/lazarex-care/. Accessed 10 Sep 2023
Patient Advocate Foundation. Co-pay relief program - patient advocate foundation. https://www.patientadvocate.org/connect-with-services/copay-relief/. Accessed 10 Sep 2023
Patient Access Network Foundation. PAN Foundation - Home. PAN Foundation. https://www.panfoundation.org/. Accessed 10 Sep 2023
Tigerlily Foundation. Programs. 2021. https://www.tigerlilyfoundation.org/programs/. Accessed 16 Sep 2023
Cancer research driven by patients and technology. Cancer Discov. 2019;9:OF1.
Schindler TM, Grieger F, Zak A, Rorig R, ChowdaryKonka K, Ellsworth A, et al. Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields. PLoS ONE. 2020;15:1–15.
American Cancer Society Cancer Action Network. Barriers to patient enrollment in therapeutic clinical trials for cancer. American Cancer Society Cancer Action Network. 2018. https://www.fightcancer.org/policy-resources/barriers-patient-enrollment-therapeutic-clinical-trials-cancer. Accessed 10 Sep 2023
Pharmaceutical Research and Manufacturers of America. Five key strategies for enhancing diversity in clinical trials. https://phrma.org/resource-center/Topics/Equity/Five-Key-Strategies-for-Enhancing-Diversity-in-Clinical-Trials. Accessed 10 Sep 2023
Stober Murray M. Co-creating global capacity for systematic patient engagement. DIA Globa Forum. 2021. https://globalforum.diaglobal.org/issue/april-2021/co-creating-global-capacity-for-systematic-patient-engagement/. Accessed 10 Sep 2023
Center for Information and Study on Clinical Research Participation. The importance of diversity in clinical trials – video. Center for Information and Study on Clinical Research Participation. 2023. https://www.ciscrp.org/the-importance-of-diversity-in-clinical-research-video/. Accessed 10 Sep 2023
Challenger R, Ferraro J. 6 practical ways to increase diversity in clinical trials. Clinical Leader. 2020. https://www.clinicalleader.com/doc/practical-ways-to-increase-diversity-in-clinical-trials-0001. Accessed 10 Sep 2023
Fashoyin-Aje LA, Tendler C, Lavery B, Ghiorghiu S, Gerald B, Kalidas C, et al. Driving diversity and inclusion in cancer drug development - industry and regulatory perspectives, current practices, opportunities, and challenges. Clin Cancer Res. 2023;OF1–7.
Acuña-Villaorduña A, Baranda JC, Boehmer J, Fashoyin-Aje L, Gore SD. Equitable access to clinical trials: how do we achieve it? Am Soc Clin Oncol Educ Book. 2023;43:e389838.
Garrick O, Mesa R, Ferris A, Kim ES, Mitchell E, Brawley OW, et al. Advancing inclusive research: establishing collaborative strategies to improve diversity in clinical trials. Ethn Dis. 2022;32:61–8.
Author information
Authors and Affiliations
Contributions
V.L., K.C., and J.R. wrote the main manuscript text. V.L. organized the manuscript thematically and incorporated all annotated and non-annotated references. M.K. revised it critically for important intellectual content and to include the patient voice and perspective into the manuscript.
Corresponding author
Ethics declarations
Competing interests
Authors Leach and Regnante received research and writing support from the Tigerlily Foundation as consultants. Cornish is an employee of the Tigerlily Foundation. Karmo is the Founder and CEO of the Tigerlily Foundation.
Conflict of Interest
Authors Leach and Regnante received research and writing support from the Tigerlily Foundation as consultants. Cornish is an employee of the Tigerlily Foundation. Karmo is the Founder and CEO of the Tigerlily Foundation.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Informed Consent
Not applicable.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Karmo, M., Cornish, K., Leach, V. et al. Patients Drive Authentic Trusted Solutions for Inclusive Clinical Trials. Curr Breast Cancer Rep 16, 76–83 (2024). https://doi.org/10.1007/s12609-024-00526-5
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12609-024-00526-5