Table 3 Binary logistic regressions of variables associated with sharing, ICombinedER, IControlER, ACP, or UCP with non-DSMB members by the DSMB
ICombinedER A Hosmer-Lemeshow Test (χ 2 = 1.94, D.F = 6, p = 0.93); [Coded as No, do not share the ICombinedER (0), Yes, share the ICombinedER (1)] n = 195 | MI sensitivity analysis for ICombinedER B n = 264 | |
Odds ratio (95% CI); p value | Odds ratio (95% CI); p value | |
The respondent has been involved with more than 15 trials | 0.77 (0.31, 1.89); 0.558 | 0.74 (0.31, 1.75); 0.484 |
The respondent has been involved with more than 15 trials that had a DSMB monitoring the trial | 0.82 (0.36, 1.84); 0.632 | 0.73 (0.35, 1.55); 0.414 |
The respondent has been involved with more than 15 trials that had some form of private industry sponsorship | 1.29 (0.61, 2.76); 0.534 | 1.32 (0.56, 3.10); 0.514 |
Primary profession by training | ||
● Other (reference category) | 1 | 1 |
● Mathematician/statistician/biostatistician | 0.25 (0.07, 0.89); 0.019 | 0.40 (0.13, 1.29); 0.123 |
● Methodological scientist/research Methodologist | 0.50 (0.10, 2.43); 0.357 | 0.84 (0.20, 3.57); 0.813 |
Usual work setting of respondents | ||
● Other (reference category) | 1 | 1 |
● University or academic institution | 0.94 (0.44, 2.02); 0.869 | 0.96 (0.49, 1.85); 0.892 |
● Private/contracted research company | 1.11 (0.39, 3.17); 0.836 | 1.13 (0.38, 3.37); 0.820 |
IControlER A Hosmer-Lemeshow test (χ 2 = 4.526, D.F = 8, p = .807); [Coded as Yes, share the IControlER (0), No, do not share the IControlER (1)] n = 195 | MI sensitivity analysis for IControlER B n = 264 | |
Odds ratio (95% CI); p value | Odds ratio (95% CI); p value | |
The respondent has been involved with more than 15 trials | 0.87 (0.36, 2.12); 0.774 | 0.78 (0.34, 1.80); 0.551 |
The respondent has been involved with more than 15 trials that had a DSMB monitoring the trial | 0.82 (0.35, 1.90); 0.674 | 0.94 (0.40, 2.19); 0.875 |
The respondent has been involved with more than 15 trials that had some form of private industry sponsorship | 2.92 (1.31, 6.52); 0.012 | 2.79 (1.11, 7.00); 0.031 |
Primary profession by training | ||
● Other (reference category) | 1 | 1 |
● Mathematician/statistician/biostatistician | 0.70 (0.26, 1.88); 0.505 | 0.68 (0.26, 1.80); 0.437 |
● Methodological scientist/research Methodologist | 0.38 (0.11, 1.34); 0.154 | 0.42 (0.13, 1.36); 0.146 |
Usual work setting of respondents | ||
● Other (reference category) | 1 | 1 |
● University or academic institution | 0.10 (0.47, 2.12); 0.993 | 0.99 (0.49, 1.99); 0.977 |
● Private/contracted research company | 1.06 (0.36, 3.10); 0.900 | 1.28 (0.39, 4.19); 0.672 |
ACP A Hosmer-Lemeshow test (χ2 = 2.39, D.F = 7, p = 0 .94); [Coded as Yes, share the ACP (0), No, do not share the ACP (1)] n = 196 | MI sensitivity analysis for ACP B n = 264 | |
Odds ratio (95% CI); p value | Odds ratio (95% CI); p value | |
The respondent has been involved with more than 15 trials | 1.08 (0.45, 2.59); 0.868 | 1.06 (0.46, 2.45); 0.883 |
The respondent has been involved with more than 15 trials that had a DSMB monitoring the trial | 1.73 (0.75, 4.00); 0.237 | 1.75 (0.48, 6.41); 0.362 |
The respondent has been involved with more than 15 trials that had some form of private industry sponsorship | 1.48 (0.66, 3.32); 0.358 | 1.41 (0.58, 3.46); 0.438 |
Primary profession by training | ||
● Other (reference category) | 1 | 1 |
● Mathematician/statistician/biostatistician | 0.59 (0.22, 1.62); 0.305 | 0.67 (0.27, 1.65); 0.375 |
● Methodological scientist/research Methodologist | 0.85 (0.23, 3.24); 0.830 | 0.85 (0.19, 3.69); 0.819 |
Usual work setting of respondents | ||
● Other (reference category) | 1 | 1 |
● University or academic institution | 1.19 (0.55, 2.60); 0.694 | 0.93 (0.43, 1.98); 0.838 |
● Private/contracted research company | 0.50 (0.18, 1.39); 0.189 | 0.51 (0.19, 1.39); 0.186 |
UCP A Hosmer-Lemeshow test (χ2 = 2.664, D.F = 7, p = .914); [Coded as Yes, share the UCP (0), No, do not share UCP (1)] n = 192 | MI sensitivity analysis for UCP B n = 264 | |
Odds ratio (95% CI); p value | Odds ratio (95% CI); p value | |
The respondent has been involved with more than 15 trials | 1.65 (0.69, 3.92); 0.266 | 1.51 (0.63, 3.63); 0.350 |
The respondent has been involved with more than 15 trials that had a DSMB monitoring the trial | 1.04 (0.46, 2.35); 0.937 | 1.01 (0.31, 3.32); 0.987 |
The respondent has been involved with more than 15 trials that had some form of private industry sponsorship | 1.11 (0.52, 2.39); 0.798 | 1.06 (0.53, 2.15); 0.863 |
Primary profession by training | ||
● Other (reference category) | 1 | 1 |
● Mathematician/statistician/biostatistician | 0.60 (0.22, 1.62); 0.341 | 0.66 (0.29, 1.51); 0.326 |
● Methodological scientist/research Methodologist | 0.28 (0.08, 0.99); 0.052 | 0.26 (0.074, 0.94); 0.039 |
Usual work setting of respondents | ||
● Other (reference category) | 1 | 1 |
● University or academic institution | 1.28 (0.60, 2.71); 0.526 | 1.00 (0.43, 2.31); 0.995 |
● Private/contracted research company | 0.67 (0.25, 1.79); 0.416 | 0.68 (0.22, 2.09); 0.481 |