Table 2.
Details of the assessment of the internal pilots
| Frequency (%) | |
|---|---|
| Design followed? (Yes/No)a | |
| Yes | 49 (91%) |
| No | 5 (9%) |
| Extended due to poor recruitment | 2 (40%) |
| Internal pilot delayed | 3 (60%) |
| Committees involved in reviewb | |
| IDSMC only | 3 (6%) |
| TSC only | 17 (35%) |
| IDSMC, TSC | 23 (47%) |
| IDSMC, TSC, TMG | 2 (4%) |
| TSC, sponsor | 3 (6%) |
| Continuation to main trial? (Yes/No) | |
| Yes, met criteria | 33 (58%) |
| Yes, did not meet criteria | 14 (25%) |
| Underwent a second reviewc | 5 (36%) |
| Continued with close monitoring | 3 (21%) |
| Recovery plan put in place | 3 (21%) |
| No reported actions taken | 4 (29%) |
| Yes, unclear whether criteria met | 9 (16%) |
| Decision on hold | 1 (2%) |
| No | 0 (0%) |
| Number of planned pilot sites given?d (Yes/No) | |
| Yes | 44 (79%) |
| No | 12 (21%) |
| If yes, specifically named? | |
| Yes | 16 (36%) |
| No | 28 (64%) |
| Number of planned pilot sites | |
| Median | 6 (5, 10) |
| (interquartile range (IQR)) | |
| Min, Max | 2, 80 |
| Number of planned sites for full trialf | |
| Median (IQR) | 20 (13, 30) |
| Min Max | 3, 300 |
| Adherence to plan regarding number of pilot sites?e (Yes/No) | |
| Yes | 28 (72%) |
| No | 10 (26%) |
| Opened further sites | 6 (60%) |
| Opened fewer sites | 4 (40%) |
| Missing | 6 |
aDesign not given in the protocol/proposal for 1 trial; unclear from the available information for 2 trials
bNot given for 8 trials
cSecond review involved revised recruitment targets; 1 trial underwent close monitoring alongside second review
dNot applicable for 1 trial – no sites since recruitment takes place online
eNumber of planned pilot sites not given for 12 trials
fIncluding pilot sites; not given for 2 trials
IDSMC Independent Data and Safety Monitoring Committee, TSC Trials Steering Committee, TMG Trial Management Group