Systematic Review and Meta-Analysis of the Magnitude of Structural, Clinical, and Physician and Patient Barriers to Cancer Clinical Trial Participation

Abstract

BackgroundBarriers to cancer clinical trial participation have been the subject of frequent study, but the rate of trial participation has not changed substantially over time. Studies often emphasize patient-related barriers, but other types of barriers may have greater impact on trial participation. Our goal was to examine the magnitude of different domains of trial barriers by synthesizing prior research.MethodsWe conducted a systematic review and meta-analysis of studies that examined the trial decision-making pathway using a uniform framework to characterize and quantify structural (trial availability), clinical (eligibility), and patient/physician barrier domains. The systematic review utilized the PubMed, Google Scholar, Web of Science, and Ovid Medline search engines. We used random effects to estimate rates of different domains across studies, adjusting for academic vs community care settings.ResultsWe identified 13 studies (nine in academic and four in community settings) with 8883 patients. A trial was unavailable for patients at their institution 55.6% of the time (95% confidence interval [CI] = 43.7% to 67.3%). Further, 21.5% (95% CI = 10.9% to 34.6%) of patients were ineligible for an available trial, 14.8% (95% CI = 9.0% to 21.7%) did not enroll, and 8.1% (95% CI = 6.3% to 10.0%) enrolled. Rates of trial enrollment in academic (15.9% [95% CI = 13.8% to 18.2%]) vs community (7.0% [95% CI = 5.1% to 9.1%]) settings differed, but not rates of trial unavailability, ineligibility, or non-enrollment.ConclusionsThese findings emphasize the enormous need to address structural and clinical barriers to trial participation, which combined make trial participation unachievable for more than three of four cancer patients.

Disparities in Clinical Trial Access Across US Urban Areas

“…A lack of geographically convenient clinical trial sites hinders study participation, 1,2 particularly for rural residents. 3 But even in more densely populated regions, where most US residents live, trial locations may not be optimized to maximize access.…”

Teletrials: implementation of a new paradigm for clinical trials

“…We acknowledge that this model represents a change to usual process and therefore requires assessment, transparency and strong support and advocacy to overcome barriers to clinical trial participation …”

Improving access to cancer clinical trials by reducing the financial burden

“…Access to cancer care and clinical trials is a complex issue requiring a multipronged approach to ensure that every patient with cancer can get the care that he or she deserves. 19 Sustainable solutions will require investments and changes at all levels of the health care system. Institutional change alone will not alleviate the need for continued efforts to affect health care and reimbursement policies at the state and national levels, but it can help to inform the process.…”

“…Access to cancer care and clinical trials is a complex issue requiring a multipronged approach to ensure that every patient with cancer can get the care that he or she deserves . Sustainable solutions will require investments and changes at all levels of the health care system.…”