Barriers to therapeutic clinical trials enrollment: differences between African-American and white cancer patients identified at the time of eligibility assessment.

BACKGROUND: Clinical trials (CTs) are the mechanism by which research is translated into standards of care. Low recruitment among underserved and minority populations may result in inequity in access to the latest technology and treatments, compromise the generalizability, and lead to failure in identification of important positive or negative treatment effects among under-represented populations. METHODS: Data were collected over a 39-month period on patient eligibility for available therapeutic cancer CTs. Reasons for ineligibility and refusal were collected. The data were captured using an automated software tool for tracking eligibility pre-enrollment. We examined characteristics associated with being evaluated for a trial, and reasons for ineligibility and refusal, overall and by patient race. RESULTS: African-Americans (AAs) were more likely than Whites to be ineligible (odds ratio, (OR) = 1.26, 95% confidence interval (CI) = 1.0-1.58) and if eligible, to refuse participation (OR = 1.79, 95% CI = 1.27-2.52), even after adjusting for insurance, age, gender, study phase, and cancer type. White patients were more likely to be ineligible due to study-specific or cancer characteristics. AAs were more likely to be ineligible due to mental status or perceived noncompliance. Whites were more likely to refuse due to extra burden, due to concerns with randomization and toxicity, or because they express a positive treatment preference. AAs were more likely to refuse because they were not interested in CTs, because of family pressures, or they felt overwhelmed (NS)). DISCUSSION: This study is the first to directly compare ineligibility and refusal rates and reasons captured prospectively in AA and White cancer patients. The data are consistent with earlier studies that indicated that AA patients more often are deemed ineligible and, when eligible, more often refuse participation. However, differences in reasons for ineligibility and refusal by race have implications for a cancer center to participate in CTs appropriate for the population of patients served. On a broader scale, consideration should be given to modifying eligibility criteria and other design aspects to permit broader participation of minority and other underserved groups.

Acute myeloid leukemia: how the uninsured fare.

BACKGROUND: African American race and uninsurance are associated with undertreatment and poor survival in solid tumor cancers. This relationship has not been examined in acute myeloid leukemia (AML) where absence of treatment or treatment delays can result in death within weeks or months. Induction followed by consolidation treatment, in contrast, has a high probability for remission or cure. We examined the relationship between race and health insurance and inpatient chemotherapy and survival in AML patients between the ages of 21 and 64 years. We also examined inpatient costs associated with inpatient treatment. METHODS: We used population-based data from the Virginia Cancer Registry and the Virginia Health Information discharge data for patients diagnosed with AML between 1999 and 2006 (n = 523). Adjusted logistic regression was used to measure the relationship between the independent variables and chemotherapy. We used the Cox proportional hazards method to estimate survival. RESULTS: Uninsured patients were more likely to be untreated than their privately insured counterparts (odds ratio, 4.40; 95% confidence interval, 1.85-10.49) and had a higher likelihood of death (hazard ratio, 1.29; 95% confidence interval, 1.02-1.84). Once treatment was adjusted in the survival analyses, differences between insurance groups were not statistically significant. The median 1-year cost of inpatient care following diagnosis for patients who received chemotherapy exceeded $100,000. CONCLUSION: This study addressed the urgency for health insurance that affords access to care. Without treatment, the outcome of AML is death within only a few months; with treatment, the chance for long-term remission or even cure exists.