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

Posted: Oct 04, 2012
Clin Trials. [Epub ahead of print]
KEYWORDS: Knowledge/Attitudes/Beliefs, Logistics/Transportation, Cost/Insurance, Remuneration, Attitudes, Insurance Coverage, Eligibility, Randomization, Study Burden, Minority Groups, Black or African-American, White or Caucasian, Cancer


Understanding differences in reasons for ineligibility or refusal by race can help cancer centers determine whether a proposed clinical trial is appropriate for the population of patients it serves.

Why this item may be useful

The authors compare reasons for ineligibility and refusal by race and suggest that modifying eligibility criteria and other aspects of trial design could broaden participation of minorities and other underserved groups. The article also includes suggestions for overcoming specific barriers.


  • The authors suggest the following trial design modifications: reimburse expenses related to participation (i.e., costs not covered by insurance as well as indirect costs such as travel and child care), require fewer clinic visits, or provide for assessments at locations more convenient to participants.
  • African-American patients were more likely than Whites to be ineligible for subjective reasons based on the judgment of the nurse or physician; for example, mental status (i.e., perceived or documented inability to provide informed consent) or expected noncompliance based on history of missed appointments, drug abuse, etc. Whites were more likely to be ineligible due to study-specific or cancer characteristics.
  • Eligible African Americans were more likely to refuse participation due to lack of interest, family pressures, and feeling overwhelmed.