Table 1.
Number and percent of patients ineligible for clinical trials, overall and by race
| African-American, n = 341
|
White, n = 507
|
Total, N = 848
|
|
|---|---|---|---|
| n (%) | n (%) | N (%) | |
| Comorbidity | 68 (19.8) | 91 (18.0) | 159 (18.8) |
| Prior treatment* | 48 (14.0) | 99 (19.6) | 147 (17.3) |
| Extent of disease | 53 (15.4) | 76 (15.0) | 129 (15.2) |
| Histopathology nonmatch | 33 (9.6) | 45 (8.9) | 78 (9.2) |
| Second/multiple primary | 16 (4.7) | 27 (5.3) | 43 (5.1) |
| No available protocol | 10 (2.9) | 25 (4.9) | 35 (4.1) |
| Performance status | 15 (4.4) | 15 (3.0) | 30 (3.5) |
| Interval since diagnosis or treatmenta | 8 (2.3) | 20 (4.0) | 28 (3.3) |
| Stage of disease | 10 (2.9) | 18 (3.6) | 28 (3.3) |
| Does not meet trial-specific eligibility requirements | 9 (2.6) | 19 (3.8) | 28 (3.3) |
| Physician decisionb | 12 (3.5) | 15 (3.0) | 27 (3.2) |
| Anticipated noncompliance* | 21 (6.1) | 5 (0.99) | 26 (3.1) |
| Cancer characteristics | 7 (2.0) | 16 (3.2) | 23 (2.7) |
| Mental status/cognitive impairmentc** | 13 (3.8) | 3 (0.59) | 16 (1.9) |
| Age exclusion | 2 (0.58) | 5 (0.99) | 7 (0.8) |
| Enrolled in competing study | 1 (0.29) | 4 (0.79) | 5 (0.6) |
| Language barrier | 0 (0.00) | 1 (0.20) | 1 (0.1) |
| Missing reason for ineligibility | 17 (5.0) | 21 (4.2) | 38 (4.5) |
a
Includes evaluations for patients who had insufficient time or too much time elapsed to meet a particular eligibility criterion.
b
Physician determined that a patient was not a good candidate for a trial or physician preferred standard therapy for the patient.
c
Judged by research staff or attending physician as patient having an inability to comprehend informed consent.
*
Chi-squared test, 0.001 <p > 0.0001.
**
Chi-squared test, p <0.0001.