Table 3 Summary of Results for Sharing Certain Interim Results
Interim Combined Event Rate | |
1 a) 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; % [95% CI]), N = 262 |
Yes | 168; 64.1% [58.0% to 69.9%]; |
With whom?* | |
B. The Steering Committee A. The Sponsor C. The Investigator(s) D. The Funder(s) E. Other, Please Specify: • Institutional Review Board or Research Ethics Boards, • Regulatory Bodies, • Blinded Statistician on Steering Committee, • Study Statistician • Participants • Professional public | 142; 54.2% [48.2% to 60.2%]; 101; 38.5% [32.7% to 44.4%]; 80; 30.5% [25.0% to 36.1%]; 64; 24.4% [19.2% to 29.6%]; 15; 5.7% [2.9% to 8.5%]; |
No (F. None of the Above) | 94; 35.9% [30.1% to 41.7%] |
1 b) 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) Question 1 b. answered only by those who answered A, B, C, D or E to Question 1 a. | |
Results (Mean [95% CI]; Median [IQR]), N = 146 | |
6.97 [6.62 to 7.31]; 7 [6-8] | |
Interim Control Event Rate | |
2 a) During an ongoing Randomized Controlled Trial (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; % [95% CI]), N = 237 |
Yes | 88; 37.1% [31.0% to 43.3%] |
With whom?* | |
B. The Steering Committee C. The Investigator(s) A. The Sponsor D. The Funder(s) E. Other, Please Specify: • Institutional Review Board or Research Ethics Boards, • Regulatory Bodies • Professional Public • Study Statistician | 60; 25.3% [19.8% to 30.9%] 35; 14.8% [10.3% to 19.3%] 33; 13.9% [9.5% to 18.3%] 30; 12.7% [8.4% to 16.9%] 22; 9.3% [5.6% to 13.0%] |
No (F. None of the Above) | 149; 62.9% [56.7% to 69.0%] |
2 b) 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) Question 2 b. answered only by those who answered A, B, C, D or E to Question 2 a. | |
Results (Mean [95% CI]; Median [IQR]), N = 72 | |
7.03 [6.55 to 7.50]; 7 [5-8] | |
Adaptive Conditional Power | |
3 a) 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; % [95% CI]), N = 224 |
Yes | 80; 35.7% [29.4% to 42.0%] |
With whom?* | |
B. The Steering Committee A. The Sponsor C. The Investigator(s) D. The Funder(s) E. Other, Please Specify • Trial statistician, • Pre-specified members of the sponsor and steering committee, • Professional public, • Institutional Review Board or Research Ethics Boards | 45; 20.1% [14.8% to 25.3%] 34; 15.2% [10.5% to 19.9%] 27; 12.1% [7.8% to 16.3%] 22; 9.8% [5.9% to 13.7%] 21; 9.4% [5.6% to 13.2%] |
No (F. None of the Above) | 144; 64.3% [58.0% to 70.6%] |
3 b) 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) Question 3 b. answered only by those who answered A, B, C, D or E to Question 3 a. | |
Results (Mean [95% CI]; Median [IQR]), N = 66 | |
6.64 [6.08 to 7.20]; 7 [5-8] | |
Unconditional Conditional Power | |
4 a) 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; % [95% CI]), N = 208 |
Yes | 82; 39.4% [32.8% to 46.1%] |
With whom?* | |
B. The Steering Committee A. The Sponsor C. The Investigator(s) D. The Funder(s)* E. Other, Please Specify • Pre-specified with whom such as selected members of the sponsor or funder who do not see patients • Study statistician • Steering committee • Professional public • Institutional Review Board or Research Ethics Boards | 57; 27.4% [21.3% to 33.5%] 42; 20.2% [14.7% to 25.6%] 30; 14.4% [9.6% to 19.2%] 29; 13.9% [9.2% to 18.6%] 17; 8.2% [4.4% to 11.9%] |
No (F. None of the Above) | 126; 60.6% [53.9% to 67.2%] |
4 b) 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) Question 4 b. answered only by those who answered A, B, C, D or E to Question 4 a | |
Results (Mean [95% CI]; Median [IQR]), N = 67 | |
6.64 [6.08 to 7.20]; 7 [5-8] | |