The authors make the case that such a bayesian approach can increase the robustness of information from small trials and can be used to help design and provide justification for such trials.
However, if the current trial demonstrates that there is no additional benefit from early physiotherapy, this would provide the rationale (and the ethical justification) for randomised trials of specific physiotherapeutic modalities.
Information leaflets will be made available to local centres, in appropriate languages, which explain the justification for the trial, the process of trial entry and follow up.
This justification for the trial is diminished, however, by the passage of 12 years since the crimes were committed.
There is considerable scientific justification for this trial, with strong data in support of: a) the poor outcome for those failing CPAP, b) the capacity to identify such infants early, c) the potential for MIST to alter the outcome in such infants, and d) the potential benefits of surfactant delivery in the spontaneously breathing infant [ 25].
65 The value of a research question, as well as the ethical and scientific justification for a trial, depend to a large degree on the uncertainty of the comparative benefits or harms of the interventions, which depends in turn on the existing body of knowledge on the topic.
Given the high mortality associated with AKI, the lack of specific RRT interventions shown to reduce mortality, and current practice variation, the results of our pilot trial provide justification for a larger trial of hemofiltration vs. hemodialysis that will be adequately powered to evaluate meaningful clinical outcomes.
The justifications for these trials being the first-in-class are listed in Additional file 3.
That being so, there seems to be little justification for conducting the trials.
32 The justification for promoting clinical trials in paediatric patients is to ensure that they receive medicines that have been scientifically tested for both efficacy and safety.
