March 26, 2025
Author: Carol Wang, Ph.D., Director of Clinical Research, We Are Here
Clinical trials are crucial for many patients, by providing access to cutting-edge treatments and playing an important role in advancing medicine. However, many patients – especially those from underserved communities- face obstacles that limit their ability to participate. Common barriers include logistical challenges, financial concerns, and a lack of information often contributes to healthcare disparities and reduces trial diversity and participation (1,2).
Fortunately, patient navigation services, which guide individuals through the complexities of their healthcare planning and clinical trials, is a promising solution to help patients overcome these obstacles and open the doors to greater clinical trial participation. Patient navigators guide patients through the complex clinical trial process, helping them understand their options, manage practical challenges, and even address financial concerns. Patient navigation is helping more people improve their quality of life after a diagnosis, by addressing their needs holistically, and helping them access clinical trials.
Why Patient Navigation Matters for Clinical Trial Access
- Increases Awareness and Education of Trials
One of the biggest hurdles patients face is not knowing that clinical trials are an option for them. Additionally, many people are unaware of what clinical trials entail or assume they are ineligible. Patient navigators help increase awareness and education of trials by educating patients on the process and benefits of clinical trials, debunking common misconceptions, and explaining eligibility requirements. Research has shown that educational support from a patient navigator can potentially boost trial enrollment (3,4). Navigators are especially valuable in communities where clinical trial awareness is low.
- Makes Logistics Easier
Once patients are informed of trial options, they often face practical obstacles. These obstacles include travel to trial sites, arrangement of childcare, and management of their schedules around appointments. Patient navigators step in to address these logistical needs whether that is helping arrange transportation for patients or coordinating appointments to fit into patients’ individual schedules (5). By aiding in logistical management, navigators help patients feel that participation in trials is feasible, thereby boosting trial enrollment.
- Addresses Financial Concerns
Financial costs to clinical trial participation is a significant barrier, especially for low-income patients. Even when trials cover treatment costs, there are often additional costs such as transportation, accommodations, childcare, or lost income due to time off work. Financial counseling from patient navigators can help patients navigate reimbursements and access financial assistance. One study tested a cancer care financial equity program in which participants received financial navigation services and financial assistance. Participants of the program saw greater clinical trial enrollment compared to those who were not enrolled in the program (6).
- Builds Trust and Community
Historically, mistrust of the healthcare system can deter individuals from underserved communities from participating in clinical trials. Patient navigators, especially those who share a similar cultural or linguistic background with patients, help bridge this gap. Through culturally sensitive health communication, patient navigators build trust and address the specific concerns that these groups may have about research participation.
Conclusion
Patient navigation is a powerful tool for expanding access to clinical trials, especially for individuals in underserved communities. By helping patients overcome educational, logistical, and financial barriers, navigators play a vital role in fostering greater inclusivity, diversity, and accessibility in clinical research. The We Are Here platform supports patients and navigators by connecting them to personalized health, medical, and psychosocial resources tailored to each patient’s unique needs.
About the Author
Dr. Wang is an accomplished social and health research scientist whose work focuses on community-based participatory methods and patient-centered outcomes. She earned her PhD from the University of Houston, where she was a Susan G. Komen Research Fellow at the University of Texas, MD Anderson Cancer Center, and completed a postdoctoral fellowship at MD Anderson through the CPRIT cancer prevention research training program. Her work has been funded by the American Association for Cancer Research, National Cancer Institute, American Psychological Association, and Susan G. Komen Foundation.
References
1Ghebre, R. G., Jones, L. A., Wenzel, J. A., Martin, M. Y., Durant, R. W., & Ford, J. G. (2014). State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual. Cancer, 120(Suppl 7), 1122–1130. https://doi.org/10.1002/cncr.28570
2Uveges, M. K., Lansey, D. G., Mbah, O., Gray, T., Sherden, L., & Wenzel, J. (2018). Patient navigation and clinical trial participation: A randomized controlled trial design. Contemporary Clinical Trials Communications, 12, 98–102. https://doi.org/10.1016/j.conctc.2018.09.003
3Mittal, N., Saha, A., Avutu, V., Monga, V., Freyer, D. R., & Roth, M. (2022). Shared barriers and facilitators to enrollment of adolescents and young adults on cancer clinical trials. Scientific Reports, 12(1), 3875. https://doi.org/10.1038/s41598-022-07703-5
4Freund, K. M., Battaglia, T. A., Calhoun, E., Darnell, J. S., Dudley, D. J., Fiscella, K., Hare, M. L., LaVerda, N., Lee, J. H., Levine, P., Murray, D. M., Patierno, S. R., Raich, P. C., Roetzheim, R. G., Simon, M., Snyder, F. R., Warren-Mears, V., Whitley, E. M., Winters, P., Young, G. S., … Writing Group of the Patient Navigation Research Program (2014). Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. Journal of the National Cancer Institute, 106(6), dju115. https://doi.org/10.1093/jnci/dju115
5Nipp, R. D., Hong, K., & Paskett, E. D. (2019). Overcoming barriers to clinical trial enrollment. American Society of Clinical Oncology Educational Book, 39, 105–114. https://doi.org/10.1200/EDBK_243729
6Nipp, R. D., Lee, H., Powell, E., Birrer, N. E., Poles, E., Finkelstein, D., Winkfield, K., Percac-Lima, S., Chabner, B., & Moy, B. (2016). Financial burden of cancer clinical trial participation and the impact of a cancer care equity program. The Oncologist, 21(4), 467–474. https://doi.org/10.1634/theoncologist.2015-0481