Table 1.
Study characteristics and enrollment by sex, age, and race.
| Trial characteristics (20 trials) | N (Reported Race) | Caucasian N; % | Asian N; % | Black N; % | AI/AN N; % | NH/PI N; % | Multiracial N; % | Race Unknown N; % | Hispanic N; % | Total N; % | Female N; % | PPR sex (mean; 95%CI) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall | 1804 | 1423; 78.88% | 61; 3.38% | 203; 11.25% | 13; 0.72% | 4; 0.22% | 6; 0.33% | 94; 5.21% | 224; 16.45% | 2471 | 1765; 71.43% | 1.53; 1.42–1.63 |
| Blinding | ||||||||||||
| Double | 835 | 605; 72.46% | 41; 4.91% | 85; 10.18% | 4; 0.48% | 4; 0.48% | 4; 0.48% | 92; 11.02% | 57; 14.5% | 1437 | 1048; 72.93% | 1.54; 1.44–1.65 |
| Triple | 58 | 53; 91.38% | 0; 0% | 1; 1.72% | 2; 3.45% | 0; 0% | 0; 0% | 2; 3.45% | 2; 3.45% | 58 | 27; 46.55% | 1a |
| Quadruple | 911 | 765; 83.97% | 20; 2.2% | 117; 12.84% | 7; 0.77% | 0; 0% | 2; 0.22% | 0; 0% | 165; 18.11% | 976 | 690; 70.7% | 1.59; 1.43–1.75 |
| P value | 0.04b | 0.31 | 0.03c | 0.04c | 0.35 | 0.62 | 0.33 | 0.17 | 0.07 | 0.25 | ||
| Phase | ||||||||||||
| Phase I | 0 | Unreported | Unreported | Unreported | Unreported | Unreported | Unreported | Unreported | Unreported | 75 | 53; 70.67% | 1.54a |
| Phase II | 494 | 400; 80.97% | 12; 2.43% | 69; 13.97% | 7; 1.42% | 2; 0.4% | 2; 0.4% | 2; 0.4% | 85; 22.97% | 634 | 421; 66.4% | 1.43; 1.26–1.6 |
| Phase III | 750 | 639; 85.2% | 16; 2.13% | 89; 11.87% | 5; 0.67% | 0; 0% | 1; 0.13% | 0; 0% | 135; 18% | 750 | 535; 71.33% | 1.7; 1.47–1.94 |
| Phase Not Applicable | 560 | 384; 68.57% | 33; 5.89% | 45; 8.04% | 1; 0.18% | 2; 0.36% | 3; 0.54% | 92; 16.43% | 4; 1.65% | 1087 | 809; 74.43% | 1.55; 1.41–1.68 |
| P value | 0.07 | 0.44 | 0.15 | 0.02c | 0.52 | 1 | 0.22 | 0.09 | 0.07 | 0.14 | ||
| Study Country | ||||||||||||
| US | 1581 | 1316; 83.24% | 42; 2.66% | 197; 12.46% | 13; 0.82% | 2; 0.13% | 3; 0.19% | 8; 0.51% | 224; 16.45% | 2067 | 1483; 71.75% | 1.57; 1.45–1.68 |
| Foreign | 182 | 81; 44.51% | 11; 6.04% | 4; 2.2% | 0; 0% | 2; 1.1% | 2; 1.1% | 82; 45.05% | Unreported | 182 | 112; 61.54% | 1.14a |
| International | 41 | 26; 63.41% | 8; 19.51% | 2; 4.88% | 0; 0% | 0; 0% | 1; 2.44% | 4; 9.76% | Unreported | 41 | 24; 58.54% | 1.46a |
| Not Reported | 0 | Unreported | Unreported | Unreported | Unreported | Unreported | Unreported | Unreported | Unreported | 181 | 146; 80.66% | 1.47; 1.19–1.75 |
| P value | 0.21 | 0.48 | 0.33 | 0.22 | 0.12 | 0.12 | 0.08 | d | 0.16 | 0.24 | ||
| Sponsor Country | ||||||||||||
| US | 153 | 126; 82.35% | 12; 7.84% | 4; 2.61% | 3; 1.96% | 0; 0% | 0; 0% | 8; 5.23% | 2; 3.45% | 277 | 176; 63.54% | 1.38; 1.07–1.69 |
| Foreign | 1527 | 1196; 78.32% | 43; 2.82% | 184; 12.05% | 9; 0.59% | 3; 0.2% | 6; 0.39% | 86; 5.63% | 222; 17.02% | 2021 | 1472; 72.84% | 1.56; 1.45–1.67 |
| International | 124 | 101; 81.45% | 6; 4.84% | 15; 12.1% | 1; 0.81% | 1; 0.81% | 0; 0% | 0; 0% | Unreported | 173 | 117; 67.63% | 1.59; 1.52–1.65 |
| P value | 0.23 | 0.95 | 0.14 | 0.88 | 0.29 | 0.23 | 0.23 | 0.3 | 0.19 | 0.58 | ||
| Initiation Year | ||||||||||||
| 2009–2013 | 95 | 73; 76.84% | 12; 12.63% | 3; 3.16% | 1; 1.05% | 0; 0% | 0; 0% | 6; 6.32% | Unreported | 515 | 386; 74.95% | 1.56; 1.37–1.74 |
| 2014–2017 | 794 | 584; 73.55% | 19; 2.39% | 94; 11.84% | 6; 0.76% | 3; 0.38% | 4; 0.5% | 84; 10.58% | 89; 14.54% | 1041 | 739; 70.99% | 1.47; 1.3–1.64 |
| 2018–2021 | 915 | 766; 83.72% | 30; 3.28% | 106; 11.58% | 6; 0.66% | 1; 0.11% | 2; 0.22% | 4; 0.44% | 135; 18% | 915 | 640; 69.95% | 1.6; 1.45–1.76 |
| P value | 0.58 | 0.11 | 0.62 | 0.79 | 0.77 | 0.66 | 0.33 | d | 0.33 | 0.39 | ||
| Intervention Type | ||||||||||||
| Drug | 1486 | 1243; 83.65% | 30; 2.02% | 194; 13.06% | 12; 0.81% | 2; 0.13% | 3; 0.2% | 2; 0.13% | 224; 16.45% | 1626 | 1152; 70.85% | 1.54; 1.4–1.69 |
| Device | 318 | 180; 56.6% | 31; 9.75% | 9; 2.83% | 1; 0.31% | 2; 0.63% | 3; 0.94% | 92; 28.93% | None enrolled | 845 | 613; 72.54% | 1.51; 1.36–1.66 |
| P value | 0.04b | 0.06 | 0.07 | 0.11 | 0.6 | 0.25 | 0.005b | NA; NA | 0.12 | 0.82 | ||
This table depicts trial enrollment by sex, race, and ethnicity. Absolute number and proportions are shown for these demographics. Participation-to-prevalence ratios (PPRs) were calculated for female patients (PPRsex). Mean and 95% CIs are shown for PPRs. This table also depicts the results of Kruskal–Wallis significance testing for comparing demographic enrollment between by trial characteristics.
AI/AN American Indian or Alaskan Native, NH/PI Native Hawaiian or Other Pacific Islander, PPR participation-to-prevalence ratio.
aPrecludes 95% confidence interval calculation due insufficient number of observations.
bSignificant pairwise or post-hoc comparison; double/quadruple (P = 0.05).
cNo significant post-hoc comparisons.
dPrecludes p value calculation due insufficient statistical levels.