title: Barriers to therapeutic clinical trials enrollment: differences between African-American and white cancer patients identified at the time of eligibility assessment.
abstract: 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)).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Internal Medicine, Virginia Commonwealth University, Richmond, 23298-0306, USA. lpenbert@vcu.edu
authors.forename: Lynne
authors.initials: L
authors.lastname: Penberthy
authors.forename: Richard
authors.initials: R
authors.lastname: Brown
authors.forename: Maureen
authors.initials: M
authors.lastname: Wilson-Genderson
authors.forename: Bassam
authors.initials: B
authors.lastname: Dahman
authors.forename: Gordon
authors.initials: G
authors.lastname: Ginder
authors.forename: Laura A
authors.initials: LA
authors.lastname: Siminoff
mesh_terms: D000328:Adult; D001741:Black or African American / Q000523:psychology; D000368:Aged; D002986:Clinical Trials as Topic / Q000379:methods / Q000523:psychology / Q000706:statistics & numerical data; D005260:Female; D006297:Health Services Accessibility; D054625:Healthcare Disparities / Q000208:ethnology; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000208:ethnology / Q000628:therapy*; D018579:Patient Selection; D011446:Prospective Studies; D045808:Refusal to Participate / Q000208:ethnology* / Q000523:psychology; D016312:Treatment Refusal / Q000208:ethnology* / Q000523:psychology; D044465:White People / Q000523:psychology