Study: Structural, Clinical Barriers Prevent Patients From Enrolling in Clinical Trial

February 22nd, 2019

By Jill Drachenberg, Editor, Relias Media

Structural and clinical barriers are among the issues preventing cancer patients from enrolling in valuable clinical trials, according to a new analysis in the Journal of the National Cancer Institute.

Three out of four cancer patients are unable to enroll in clinical trials because of availability and eligibility issues, the researchers reported. The meta-analysis studied patients across 13 cancer trials and found:

• Local clinical trials were unavailable for 55.6% of patients.
• Inclusion or exclusion criteria led 21.5% of patients to be ineligible for trials.
• Higher rates of trial participation occurred at academic sites compared with institutional sites.

Altogether, the researchers reported, 77.1% of patients were blocked from clinical trials due to the structural and clinical barriers. “At the same time, the influence of patient-related factors and patient choice — which occurs only at the end of an extensive decision-making process — comprised only a small portion of barriers to trial participation overall,” the authors wrote.

Enrollment barriers have long been a problem in clinical trials, for both participants and investigators. Patients often are not informed of clinical trials, or may decline participation due to lack of trust, transportation issues, and concern over costs. For investigators, low enrollment can mean lack of diverse study population — which can lead to cancellation of the study.

Patient populations that have historically been mistreated by researchers may lack trust in researchers and clinical trials today. In a Q&A in the February 2019 issue of IRB Advisor, Stephanie Kraft, JD, a bioethicist at Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute, explains how researchers and IRBs can reach out to help re-establish trust and good faith with skeptical patients.

Women may also face barriers to participation in trials. Some drug trials may exclude pregnant women, or drop participants who become pregnant during the study. Investigators should consider allowing pregnant women to participate in studies and not exclude this important patient population, according to investigators in the January 2018 issue of IRB Advisor.

Low health literacy also can make it difficult for some patients to enroll in clinical trials. Low literacy can mean they do not understand the informed consent. Researchers are creating informed consent understandable to all patients, as described in the February 2019 issue of IRB Advisor.

“Only by addressing structural and clinical barriers will the participation rate in cancer treatment trials be increased in a substantial way,” researchers wrote.