May 23

Low Income Is A Barrier To Enrolling In Clinical Trials, Suggests A Study

In a recent survey, researchers affiliated with the NCI Community Oncology Research Program (NCORP) found that patients with an annual household income below USD 50,000 were less likely to participate in a clinical study of cancer than those with higher incomes. Participation rates were lower in patients with annual incomes of less than USD 20,000.

The results were published Oct. 15 at JAMA Oncology

Directed by Dr. Joseph M. Unger of the Seattle Fred Hutchinson Cancer Research Center, the study used data from a 2012 survey of cancer patients who were eligible to participate in clinical trials at eight geographically diverse cancer treatment centers and which had data on their income.

Seventeen percent of patients with annual household income of USD 50,000 or more participated in a study, the researchers reported, compared with 13% of patients with incomes of USD 50,000 or less. Participation rates were only 11% of patients with annual household income below USD 20,000.

Low Income Is A Barrier To Enrolling In Clinical Trials, Suggests A StudyA key feature of the study was that patients enrolled before they had made a decision to enter the study, Dr. Unger noted. The results confirm those from an earlier observational study by Dr. Unger and colleagues, who found that patients with annual household incomes below USD 50,000 were 27% less likely than patients with higher admissions to participate in clinical studies.

“Although each study had its own limitations and neither of them alone was definitive, the fact that very similar patterns were identified in two independent consecutive studies provides accurate evidence that the observation of income inequalities in clinical study inscriptions can be valid, “said Dr. Unger.

“The main reason that studies fail to finish is insufficient recruitment,” he continued. “If more low-income patients enrolled in studies, recruitment would end more quickly, and overall, the time to complete the study and get the results would be faster.”

According to Dr. Worta McCaskill-Stevens, head of   the Research Group on Prevention Studies and Community Oncology, a key strength of the study was that 80% of the participants were willing to state their income situations.

“This really helps us understand one of the important social factors of those involved in clinical trials,” she said. In recruiting patients for a study, Dr. McCaskill-Stevens noted, researchers need to consider that some potential participants may have experienced a lifetime of poverty, “which can be very limiting in terms of interest and ability to enroll.”

There has been a lack of data on how admission affects recruitment in clinical trials, Dr. McCaskill-Stevens continued. To address this problem, NCI plans to collect improved demographics in NCORP cancer prevention and control studies.

“This new study gives us an indication of what data can be collected, but we will need to be even more comprehensive in our data collection and analysis from now on,” she said.

A better understanding of the economics of clinical trial recruitment is now especially important, Dr. McCaskill-Stevens added, because NCI will soon require cancer prevention and control studies that predominantly include pediatric patients, adolescents, and young adults who give reference to factors such as race and way of payment of their expenses that are not part of the study. These factors have not been previously documented in most of the study results.

Although this analysis primarily examined enrollments in studies of people under the age of 65, those 65 and older are a growing demographic and poverty is also growing in that age group.

“Poverty forces those over 65 to make decisions that often diminish their willingness to have interventions to treat cancer and its side effects , which is another important factor that we need to study more carefully in the future” “Said Dr. McCaskill-Stevens.

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