People with lower incomes less likely to participate in cancer clinical trials
Only 11% of those with income below $20k join trials
In cancer research findings that could have implications for other diseases and human subjects, investigators found that patients with annual household income below $50,000 were 32% less likely to participate in a clinical trial.1
Indeed, there was a direct relationship, with trial participation decreasing as annual household income fell.
“Historically, it has not been considered necessarily something that would predict outcomes or is a crucial variable to collect,” says lead study author Joseph Unger, PhD, MS, assistant member in the public health sciences division at the Fred Hutchinson Cancer Research Center in Seattle. “At this point, I would say it is a crucial variable to collect and is probably a similar issue in other disease settings. I do think this is something for IRBs to consider.”
Unger and colleagues examined the association between annual income (<$50k vs. ≥$50k) and trial participation in a multivariable logistic regression model stratified by cancer type. They adjusted for the following factors that could potentially influence participation rates: age, sex, race (self-reported by participants), education, travel distance, and disease stage (initial diagnosis vs. recurrent disease). They also examined whether there was evidence of an income level and trial participation association in other annual levels below $50,000. The 1,262 patients with annual income were predominantly younger than 65 years (71%), female (84%), and not African American (93%). In multivariable regression, patients with annual household income below $50,000 had 32% lower odds of trial participation than higher income patients (12% vs 17%). Trial participation decreased as annual household income fell to between $20,000-$49,999 (13%); and to less than $20,000 (11%).
Incentives, not coercion
The reasons for this finding — which was first determined in an earlier study2 by some of the same researchers — are not completely understood. “Lower-income patients are likely more sensitive to marginal financial expenditures than higher-income patients,” the authors concluded. “Incentives or reimbursements may be appropriate, though they should not be coercive to patients.”
Thus, IRBs may face the dilemma of having research skewed by income or risk providing incentives to lower-income people that cannot pass ethical muster.
“We want to level the playing field in terms of access to trials on the one hand, but you don’t want to unduly influence patients with some kind of outsize [incentive],” Unger says. “That may overwhelm other considerations that are important for them. It is a tricky issue and an area where I think some research needs to be done to figure out what would be an appropriate way of compensating [lower income] patients without being overly influential.”
One approach to alleviate the financial risk associated with clinical trial participation would be to cover the “excess costs” of participation, including copayments and coinsurance. Strategies could also address issues like time off from work, childcare, and transportation, Unger and colleagues note.
The confirmation of patient income level as an independent predictor of clinical trial participation leads to an obvious moral observation about the current situation: Access to cutting edge treatment is primarily the purview of those of means.
“From the patients’ perspective, clinical trials can give them access to the most recent innovative treatments,” he says. “We want to be sure there is a level playing field as far as getting access to those treatments and that shouldn’t be dictated by someone’s income level.”
Moreover, if income is associated with health status — much as outright poverty has been clearly linked to poor outcomes — then improving representation of lower-income patients in trials would make the findings more generalizable to the population as a whole.
“If patient level income is related to cancer outcomes like survival, for example — and let’s say lower income patients have worse survival [rates] — if they are not adequately represented in trials of a new drug, that is going to end up influencing your results,” Unger says. “The overall results are not going to be quite as representative of what’s going on in the population.”
Also, greater participation of lower-income patients would allow trials to be conducted more quickly, speeding the development of new treatments, he says.
“If there’s a certain segment of the population that is unwilling or unable to participate, you are not going to enroll patients and complete trials as quickly,” he says. “You can’t formally [determine] the efficacy of new treatments as quickly, so the research slows down.”
Unger is hesitant to go beyond data gathered solely on cancer research, but concedes a similar trend could be found in other areas of study. The problem is income level is not a question that is typically asked in setting up a research protocol.
“It’s quite possible — perhaps even probable — that the same issue exists in other diseases as with cancer, which is that the cancer patients are not usually asked what their income is,” he says. “So that really limits our ability to examine this question.”
The information is typically not sought from research subjects in part because it may be seen as intrusive and become a disincentive to participate, Unger notes. In the study, Unger and colleagues used data from a prospective cooperative group survey study of barriers to participation in clinical trials conducted in eight geographically diverse cancer clinics.3 In that study, patient-level baseline characteristics, including income, were collected.
REFERENCES
- Unger JM, Gralow JR, Albain KS, et al. Patient Income Level and Cancer Clinical Trial Participation: A Prospective Survey Study. Research Letter. JAMA Oncol. Published Online: October 15, 2015. doi:10.1001/jamaoncol.2015.3924.
- Unger JM, Hershman DL, Albain KS, et al. Patient income level and cancer clinical trial participation. J Clin Oncol. 2013;31(5):536-542.
- Javid SH, Unger JM, Gralow JR, et al. A prospective analysis of the influence of older age on physician and patient decision-making when considering enrollment in breast cancer clinical trials (SWOG S0316). Oncologist. 2012;17(9): 1180-1190.
In cancer research findings that could have implications for other diseases and human subjects, investigators found that patients with annual household income below $50,000 were 32% less likely to participate in a clinical trial.
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