All ward staff was blinded to the index days, while staff in the control arm and data analysts were blinded to the trial's objectives and interventions.
When such scenarios were presented during the focus group discussion, participants denied that this happened, saying that misreporting could undermine the trial's objectives.
In doing so, a clear understanding of the trial's objectives is needed such that outcome instruments that run parallel to these goals, can be selected.
Staff of all participating wards was blinded to the index days for data collection, and staff in the wards of the control arm, as well as data analysts, were blinded to the trial's objectives and interventions.
Such an approach incorporates one or more interim PK analyses that are used to reconfigure the selection of sampling times and/or the number of participants to ensure that the trial's objectives are efficiently met for the target population.
To counteract any potential contamination of our control group being informed about the trial's objectives and potential benefit, we coached controls to not increase their hydration beyond normal intake or thirst.
In South Africa, decisions to report were sometimes related to the trial's objectives, i.e. whether the information would contribute to the success of the trial: "If I say after drinking the tablet I felt weak and tired … then they will write it … [as] the effects of the tablet.
Before vaccination related activities are initiated, local social mobilisation experts visit the residents of the main ring site around the index patient's residence, seek their consent for the trial team to approach them, through community leaders and representatives where applicable, and explain the trial's objectives and the implications of potential participation.
As one of us (HM) has proposed [ 27], research ethics committees should make research approval contingent on trial registration, and the latter should provide summary details of the trial's objectives, comparator interventions and design, sufficient to permit a preliminary judgment concerning clinical equipoise.
3 Pediatric subgroups are most commonly derived from stratifications based on age; however, other physiologic (e.g., weight) or pathophysiologic (e.g., rate of disease progression) factors that influence the exposure response profile should also be considered to ensure that the sample size is appropriate given the trial's objectives.
