The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

Abstract

OVERVIEW Fewer than 1 in 20 adult cancer patients enroll in cancer clinical trials. But although barriers to trial participation have been the subject of frequent study, the rate of trial participation has not changed substantially over time. Barriers to trial participation are structural, clinical, and attitudinal, and differ according to demographic and socioeconomic factors. In this paper, we characterize the nature of cancer clinical trial barriers, and we consider global and local strategies for reducing barriers. We also consider the specific case of adolescents with cancer, and show that the low rate of trial enrollment in this age group strongly correlates with limited improvements in cancer population outcomes compared to other age groups. Our analysis suggests that a clinical trial system that enrolls patients at higher rates produces treatment advances at a faster rate and corresponding improvements in cancer population outcomes. Viewed in this light, the issue of clinical trial enrollment is foundational, lying at the heart of the cancer clinical trial endeavor. Fewer barriers to trial participation would allow trials to be completed more quickly and would improve the generalizability of trial results. Moreover, increased accrual to trials is important to patients, since trials provide patients the opportunity to receive the newest treatments. In an era of increasing emphasis on a treatment decision-making process that incorporates the patient perspective, the opportunity for patients to choose trial participation for their care is vital.

Increased clinical trial enrollment among adolescent and young adult cancer patients between 2006 and 2012–2013 in the United States

“…14 These findings are consistent with patient accrual data from the NCI Cancer Therapy Evaluation Program, identifying clinical trial enrollment rates among AYAs that are approximately 10% of the enrollment rates among children and half the rate of adults 40-65 years old. 20 While we acknowledge that clinical trial enrollment remains low in this population, our study identified promising signs of increasing overall clinical trial participation over time in a population-based study of AYAs with NHL, HL, ALL and sarcoma, representative of over 28% of the US population. 7,16 …”

No improvement in clinical trial enrollment for adolescents and young adults with cancer at a children's hospital

“…The reason for this deficiency is likely multifactorial. The location or type of medical center, for example, may dictate whether trials are available to the patient . As discussed by Bleyer et al.…”

“…A related cause for the deficit in clinical trial participation is lack of appropriate treatment regimens for older AYA patients who have a pediatric type of cancer, resulting in he or she being managed with an adult‐based therapy instead of a pediatric approach . Research has shown that clinical trial enrollment can have a positive impact on outcomes, so this deficit can partially explain the poorer outcomes seen in the AYA population.…”

Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate

“…Described as a structural barrier to trial participation within the framework recently presented by Unger et al, 40 a lack of insurance coverage, either real or perceived, can deter both patients and providers from considering a trial. Described as a structural barrier to trial participation within the framework recently presented by Unger et al, 40 a lack of insurance coverage, either real or perceived, can deter both patients and providers from considering a trial.…”