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Table 4 Multiple linear regressions of variables associated with the perceived usefulness with sharing the ICombinedER, IControlER, ACP, or UCP

From: Exploring factors associated with views on sharing of certain interim trial result measures by the data safety monitoring board (DSMB) with non-DSMB members

 

Estimated coefficient (95% CI); p value

Sensitivity analysisD

Estimated coefficient (95% CI); p value

ICombinedER A

n = 112 (R2 = 0.11, p = 0.11)

n  = 163

The respondent has been involved with more than 15 trials

0.11 (−1.37, 1.42); 0.860

0.22 (− 1.25, 1.70); 0.746

The respondent has been involved with more than 15 trials that had a DSMB monitoring the trial

0.69 (− 0.29, 1.67); 0.230

0.69 (− 0.46, 1.83); 0.224

The respondent has been involved with more than 15 trials that had some form of private industry sponsorship

−0.35 (− 1.42, 0.77); 0.501

− 0.28 (− 1.19, 0.63); 0.547

Primary profession by training

Other (reference category)

  

Mathematician/statistician/biostatistician

0.87 (−0.17, 2.06); 0.127

0.37 (−0.64, 1.38); 0.472

Methodological scientist/research Methodologist

1.03 (−0.47, 2.47); 0.159

0.86 (−0.48, 2.21); 0.208

Usual work setting of respondents

Other (reference category)

  

University or academic institution

−0.70 (− 1.83, 0.45); 0.271

−0.59 (− 1.76, 0.60); 0.317

Private/contracted research company

−1.03 (− 2.40, 0.40); 0.139

− 0.74 (− 2.68, 1.20); 0.417

IControlER B

n  = 59 (R 2  = 0.092, p  = 0.64)

n  = 85

The respondent has been involved with more than 15 trials

0.88 (− 0.87, 2.60); 0.282

0.86 (− 0.81, 2.52); 0.301

The respondent has been involved with more than 15 trials that had a DSMB monitoring the trial

− 0.75 (− 2.44, 0.84); 0.356

−0.87 (− 2.25, 0.51); 0.214

The respondent has been involved with more than 15 trials that had some form of private industry sponsorship

0.62 (− 0.89, 1.78); 0.441

0.73 (− 0.93, 2.40); 0.372

Primary profession by training

Other (reference category)

  

Mathematician/statistician/biostatistician

1.44 (−1.88, 5.67); 0.329

1.05 (−0.57, 2.67); 0.202

Methodological scientist/research methodologist

0.96 (−1.91, 4.64); 0.534

0.45 (− 1.45, 2.34); 0.641

Usual work setting of respondents

Other (reference category)

  

University or academic institution

0.27 (−1.72, 2.09); 0.762

0.14 (−0.98, 1.26); 0.807

Private/contracted research company

0.17 (−1.89, 2.61); 0.871

0.086 (− 1.59, 1.76); 0.919

ACP C

n = 51 (R2= 0.23, p = 0.11)

n  = 77

The respondent has been involved with more than 15 trials

−0.68 (− 2.18, 0.67); 0.411

−0.58 (− 1.99, 0.83); 0.410

The respondent has been involved with more than 15 trials that had a DSMB monitoring the trial

− 0.53 (− 2.39, 1.35); 0.515

− 0.27 (− 1.48, 0.94); 0.665

The respondent has been involved with more than 15 trials that had some form of private industry sponsorship

2.35 (0.45, 4.05); 0.017

1.96 (0.48, 3.44); 0.011

Primary profession by training

Other (reference category)

  

Mathematician/statistician/biostatistician

0.52 (−1.35, 2.99); 0.614

−0.096 (− 1.54, 1.35); 0.896

Methodological scientist/research methodologist

1.64 (−0.80, 5.10); 0.279

0.78 (− 1.36, 2.92); 0.466

Usual work setting of respondents

Other (reference category)

  

University or academic institution

1.21 (−1.07, 4.32); 0.335

0.96 (− 0.78, 2.69); 0.259

Private/contracted research company

0.44 (− 2.07, 3.58); 0.779

0.235 (−1.84, 2.31); 0.815

UCP B

n = 60 (R2= 0.051, p = 0.90)

n  = 82

The respondent has been involved with more than 15 trials

0.10 (−1.78, 2.02); 0.906

0.07 (− 1.48, 1.61); 0.933

The respondent has been involved with more than 15 trials that had a DSMB monitoring the trial

−0.32 (− 2.10, 1.48); 0.738

−0.068 (− 1.64, 1.51); 0.932

The respondent has been involved with more than 15 trials that had some form of private industry sponsorship

0.22 (− 1.58, 1.88); 0.780

0.063 (− 1.38, 1.51); 0.932

Primary profession by training

Other (reference category)

  

Mathematician/statistician/biostatistician

0.060 (−2.28, 2.29); 0.955

−0.55 (− 2.50, 1.39); 0.575

Methodological scientist/research methodologist

1.45 (−1.04, 4.26); 0.256

0.86 (−1.67, 3.40); 0.497

Usual work setting of respondents

Other (reference category)

  

University or academic institution

1.00 (−1.21,,3.20); 0.405

1.04 (−0.45, 2.53); 0.169

Private/contracted research company

1.02 (−2.06, 4.34); 0.508

1.15 (−0.89, 3.20); 0.265

  1. ACP adaptive conditional power, DSMB Data Safety Monitoring Board, CI confidence interval, ICombinedER interim combined event rate, IControlER interim control event rate, UCP unconditional conditional power
  2. ACIs and standard errors based on 1000 bootstrap samples with 95% bias corrected and accelerated CIs reported in brackets
  3. BCIs and standard errors based on 997 bootstrap samples with 95% bias corrected and accelerated CIs reported in brackets
  4. CCIs and standard errors based on 995 bootstrap samples with 95% bias corrected and accelerated CIs reported in brackets
  5. DResults based on pooled results from sensitivity analysis with multiple imputation