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. Author manuscript; available in PMC: 2016 Dec 1.
Published in final edited form as: Clin Trials. 2015 Jul 7;12(6):618–626. doi: 10.1177/1740774515592881

Table 1.

Characteristics of trials by presence of English fluency requirements. Missing cells were not used for hypothesis testing/p-values.

No English Language Restriction
n (row%)
Requires English Fluency
n (row%)
P-value
Number 9,574 737
Year Opened P<0.001
 Before 1995 105 (97.2%) 3 (2.8%)
 1995–1999 462 (98.5%) 7 (1.5%)
 2000–2004 1,717 (94.9%) 93 (5.1%)
 2005–2009 4,184 (92.4%) 345 (7.6%)
 2010 and later 2,821 (91.0%) 280 (9.0%)
 Missing 285 (96.9%) 9 (3.1%)
Funding Agency P<0.001
 Industry 2,959 (98.2%) 53 (1.8%)
 NIH 1,036 (93.9%) 67 (6.1%)
 U.S. Federal Government 203 (86.8%) 31 (13.2%)
 Combination of the above 2,695 (90.8%) 274 (9.2%)
 Other 2,681 (89.6%) 312 (10.4%)
Study Type P=0.006
 Expanded Access 12 (100%) 0 (0%)
 Interventional 7,909 (93.2%) 578 (6.8%)
 Observational 1,637 (91.1%) 159 (8.9%)
 Missing 16 (100%) 0 (0%)
Intervention P<0.001
 Behavioral 691 (71.6%) 274 (28.4%)
 Biological 734 (99.6%) 3 (0.4%)
 Device 626 (94.8%) 34 (5.2%)
 Dietary Supplement 170 (95.5%) 8 (4.5%)
 Drug 5,034 (96.4%) 186 (3.6%)
 Genetic 51 (98.1%) 1 (1.9%)
 Other 1,667 (90.0%) 186 (10.0%)
 Procedure 522 (92.2%) 44 (7.8%)
 Radiation 79 (98.8%) 1 (1.3%)
Phase P<0.001
 Phase 0 63 (86.3%) 10 (13.7%)
 Phase 1 1,393 (96.2%) 55 (3.8%)
 Phase 1 | Phase 2 477 (94.6%) 27 (5.4%)
 Phase 2 2,243 (96.1%) 92 (3.9%)
 Phase 2 | Phase 3 152 (95.6%) 14 (8.4%)
 Phase 3 1,227 (95.3%) 60 (4.7%)
 Phase 4 706 (92.8%) 55 (7.2%)
 Other 3,313 (88.7%) 424 (11.4%)
Gender P<0.001
 Both 8,268 (93.0%) 618 (7.0%)
 Female 892 (90.1%) 98 (9.9%)
 Male 393 (94.9%) 21 (5.1%)
 Missing 21 (100%) 0 (0%)
Region Opened P<0.001
 Midwest 1,324 (91.4%) 124 (8.6%)
 Northeast 1,677 (89.3%) 200 (10.7%)
 South 2,367 (92.8%) 184 (7.2%)
 West 1,214 (90.3%) 130 (9.7%)
 Multi-region 2,820 (96.7%) 95 (3.3%)
 Missing 172 (97.7%) 4 (2.3%)