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Table 2 Summary of respondents’ thoughts on sharing the IControlER, ICombinedER, ACP, and UCP and its usefulness

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

Interim combined event rate

1. During an ongoing randomized controlled trial (RCT), do you think that the Data Safety Monitoring Board (DSMB) for an RCT should share the interim combined event rate with ANY of the following parties?

 Response

Results [n/N; % (95% CI)]

 YesA

168/262; 64.1% (58.0% to 69.9%)

 NoB

94/262; 35.9% (30.1% to 41.7%)

2. How useful is it to share the interim combined event rates at interim? (On a scale from 0 to 10 where 0 is Not Useful at All and 10 is Very Useful)

  (This question was answered only by those who were categorized as “Yes” to 1. (above))

Number of responses to question

Results (mean (95% CI); median [IQR])

 146

6.97 (6.62 to 7.31); 7 [6–8]

Interim control event rate

3. During an ongoing randomized controlled (RCT), do you think that the Data Safety Monitoring Board (DSMB) for an RCT should share the interim control event rate with ANY of the following parties?

Response

Results [n/N; % (95% CI)]

 YesA

88/237; 37.1% (31.0% to 43.3%)

 NoB

149/237; 62.9% (56.7% to 69.0%)

4. How useful is it to share the interim control event rates at interim? (On a scale from 0 to 10 where 0 is Not Useful at All and 10 is Very Useful)

  (This question was answered only by those who were categorized as “Yes” to 3. (above))

Number of responses to question

Results (mean (95% CI); median [IQR])

 72

7.03 (6.55 to 7.50); 7 [5–8]

Adaptive conditional power

5. During an ongoing randomized controlled trial (RCT), do you think that the Data Safety Monitoring Board (DSMB) for an RCT should share the adaptive conditional power with ANY of the following parties?

Response

Results [n/N; % (95% CI)]

 YesA

80/224; 35.7% (29.4% to 42.0%)

 NoB

144/224; 64.3% (58.0% to 70.6%)

6. How useful is it to share the adaptive conditional power at interim? (On a scale from 0 to 10 where 0 is Not Useful at All and 10 is Very Useful)

  (This question was answered only by those who were categorized as “Yes” to 5. (above))

Number of responses to question

Results (mean (95% CI); median [IQR])

 66

6.64 (6.08 to 7.20); 7 [5–8]

Unconditional conditional power

7. During an ongoing randomized controlled trial (RCT), do you think that the Data Safety Monitoring Board (DSMB) for an RCT should share the unconditional conditional power with ANY of the following parties?

Response

Results [n/N; % (95% CI)]

 YesA

82/208; 39.4% (32.8% to 46.1%)

 NoB

126/208; 60.6% (53.9% to 67.2%)

8. How useful is it to share the unconditional conditional power at interim? (On a scale from 0 to 10 where 0 is Not Useful at All and 10 is Very Useful)

  This question was answered only by those who were categorized as “Yes” to 7. (above))

Number of responses to question

Results (mean (95% CI); median [IQR])

 67

6.64 (6.08 to 7.20); 7 [5–8]

  1. ARespondent had to select any of the following parties for a Yes categorization: A. The Sponsor, B. The Steering Committee, C. The Investigator(s), D. The Funder(s), or E. Other, Please Specify)
  2. BRespondent had to select F. None of the Above for a No categorization
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ISSN: 1745-6215