This study comprehensively examined Maryland cancer patients’ participation in NCI-sponsored CTCG treatment trials. Our findings show, for the period 1999 to 2002, Maryland patients with cancer enrolled in treatment trials at higher rate included pediatric and adolescent age groups, male patients for non-sex-specific tumors and female patients for sex-specific tumors, those with private health insurance, and those residing in the Maryland National Capitol (specifically Montgomery County) and parts of the Baltimore Metro (especially Baltimore and Anne Arundel Counties) regions. In addition, there were different patterns of accrual for female and male patients on county level socioeconomic factors.
This study was modeled on the report by Sateren et al.3
that examined accrual onto NCI-sponsored treatment trials nationally for a 12-month period. Our study differs from Sateren et al. in several key ways. We present data on accrued patients, cancer rates, and accrual trends from one state for a four-year period and provide more detailed measures of material deprivation and rural residence. Although accrual data were presented for all racial/ethnic groups, because of low numbers of patients other than black or white, analyses were not possible for these groups. Additionally, while cancer sites (colorectal, lung, leukemia and lymphoma) were selected to make appropriate comparisons with the national analysis, additional cancers of significance to Maryland residents (i.e., female breast and male reproductive [prostate included]) were also examined. Although requested from NCI, accrual data on race by age group were not obtained; therefore, such analyses were not possible in this report.
From 1999 to 2002, there was an increase in accrual of Maryland patients with cancer to NCI-sponsored treatment trials. Moreover, the overall accrual rate of Maryland patients with cancer to NCI-sponsored treatment trials was comparable to national CTCG accrual rates3
. As reported elsewhere3
, accrual was highest for pediatric cancer patients and lowest among adults age 60 and over. Low accrual of adults age 60 and older is disconcerting, as they are at high risk for a cancer diagnosis and are insured through Medicare, which instituted a coverage policy for beneficiary trial participation in 2000 and amended it in July 2007.
Despite comparable cancer burden for some cancers, there were significant sex differences in accrual for Maryland cancer patients. Male and female patients had relatively similar rates for colorectal cancer, leukemia and lymphoma; however, male patients were significantly more likely to be enrolled onto treatment trials. On the other hand, despite comparable sex-specific cancer rates (reproductive cancers for male patients and breast cancer for female patients), there was significantly higher accrual of female patients to sex-specific treatment trials. The majority of Maryland’s accrual data by race is for blacks and whites. While modest fluctuations in accrual for whites occurred during this period, decline in accrual of blacks, who experience significant cancer rates, should be noted and is similar to that reported nationally3
. Decline in enrollment of African Americans warrants immediate study and may be due to factors such as distrust, lack of available trials, limited information, age, and exclusionary criteria for comorbidity (also see2,4
Lack of insurance coverage and reimbursement for trials is a real and perceived barrier to clinical trial accrual27
. Overall, the majority of Maryland patients with cancer in treatment trials were covered by health insurance. Similar to national data3
, the majority of Maryland trial patients were privately insured. However, unlike the national data3
, a lower proportion of Maryland trial patients were covered by Medicaid, a higher proportion were government insured, and the percentage of Medicare patients accrued on trials was similar to the percentage of individuals covered by Medicare in the state.
Clinical trial participation cost is a concern. The majority (60%) of patients do not take part in clinical trials due to fear of having their insurance denied 27,28
and oncologists have reported denial for routine care costs as an obstacle to enrollment27,29
. In 1998 and 1999, Maryland passed state health insurance mandates into law on coverage of trial associated clinical costs28,28
. Although the Maryland law mandates coverage for trial associated costs, restrictions in application of this law make this benefit, and other mandated health benefits, available to only 25% of the insured 28
There were substantial differences in trials accrual for Maryland regions, with higher observed than expected accrual in the National Capitol region (comprised of Montgomery and Prince George’s Counties), equivalent accrual in the rural Eastern Shore, and lower than expected accrual in rural Northwest and Southern Maryland regions. Although viewed as a wealthy county, Montgomery County has pockets of underserved communities and is the location of the NIH and its Clinical Center, which may explain higher than expected trial accrual. Prince George’s County, adjacent to Montgomery County with a large African American community, had lower than expected accrual. Unlike the lower than expected accrual observed in the rural Northwest and Southern Maryland regions, the Eastern Shore observed versus expected accrual was equivalent. This could be explained by the intensive, multi-level programs and partnership with Eastern Shore Cancer Research Network and UMSOM that includes concentrated education, trial infrastructure and outreach to the public, local physicians, and nurses to increase cancer trial accrual and availability in the rural Eastern Shore18
These findings present a compelling case for future research on declining trends in accrual of black patients onto treatment trials, differential accrual by sex for comparable prevalence of specific cancer burden, differential accrual by gender within racial/ethnic groups, and lower than expected accrual rates in Prince George’s County and rural Northwestern and Southern Maryland regions. There is a need to enhance targeted educational and outreach efforts to communities and community-based health professionals to increase trial availability and to foster trial participation, accrual and retention. Educational efforts should inform minorities and community physicians on design, regulatory and reporting aspects on clinical trials and foster public trust, health literacy, and community understanding of the importance of representative numbers in clinical research, Institutional Review Boards, informed consent, and potential for research benefits.
This study has important features. It extends existing research by Sateren et al.3
in several key areas. In the absence of individual socioeconomic data, study limitations include use of demographic data for county population and not for individual Maryland patients with cancer. Therefore, it is difficult to determine the independent effect of geography of residence and individual-level racial and socioeconomic differences on treatment trial accrual. Observed multivariable logistic regression results may be due to uncontrolled confounding by individual social and economic resources, as well as barriers to participation, which may bias results in an unpredictable manner. We examined accrual of Maryland patients with cancer to NCI-sponsored treatment trials from CTCGs; thus, individuals participating in prevention or industry trials or investigator-initiated treatment trials supported by NCI cannot be commented on and results cannot be extended to the general population of patients participating in all clinical trials.
This examination of participation of Maryland patients with cancer in NCI-sponsored treatment trials has identified significant disparities in trial accrual among Maryland patients with cancer. Findings provide a compelling argument for intensive, ongoing efforts to understand and address barriers to clinical research and trial participation in Maryland and for tailored and targeted educational efforts to improve accrual.