Table 1 Feasibility objectives
Objective | Description |
|---|---|
Recruitment rate | The number of identified eligible subjects in a given amount of time, at the proposed clinical setting. |
Acceptance rate | The fraction of identified eligible subjects who will be willing to participate in the proposed clinical trial. |
Dropout rate and safety | Dropout rate will be reported as the fraction of enrolled subjects who will be dropped from the study for any reason. Reported reasons for subject drop-out will be recorded and analysed to confirm safety for both the treatment and placebo administration to enrolled subjects. |
Primary outcome identification and sample size estimate | The primary outcome for the future main clinical trial will be identified among significant immune profile changes detected in the pilot trial. Data from the pilot trial will also be used to estimate an appropriate sample size for the main trial. |
Secondary outcomes identification | Collected data in the pilot trial will be used to identify promising secondary outcome measures. |