Overcoming Barriers to Clinical Trial Enrollment

Abstract

Clinical trials are imperative for testing novel cancer therapies, advancing the science of cancer care, and determining the best treatment strategies to enhance outcomes for patients with cancer. However, barriers to clinical trial enrollment contribute to low participation in cancer clinical trials. Many factors play a role in the persistently low rates of trial participation, including financial barriers, logistical concerns, and the lack of resources for patients and clinicians to support clinical trial enrollment and retention. Furthermore, restrictive eligibility criteria often result in the exclusion of certain patient populations, which thus adds to the widening disparities seen between patients who enroll in trials and those treated in routine practice. Moreover, additional factors, such as difficulty by patients and clinicians in coping with the uncertainty inherent to clinical trial participation, contribute to low trial enrollment and represent key components of the decision-making process. Specifically, patients and clinicians may struggle to assess the risk-benefit ratio and may incorrectly estimate the probability and severity of challenges associated with clinical trial participation, thus complicating the informed consent process. Importantly, research has increasingly focused on overcoming barriers to clinical trial enrollment. A promising solution involves the use of patient navigators to help enhance clinical trial recruitment, enrollment, and retention. Although clinical trials are essential for improving and prolonging the lives of patients with cancer, barriers exist that can impede trial enrollment; yet, efforts to recognize and address these barriers and enhance trial enrollment are being investigated.