Descriptive presentations of the proposed primary and secondary outcomes will also be made to inform a sample size calculation for a large-scale trial and decisions as to whether their inclusion would be informative in a future trial (objective 8).
There are two types of criteria used to determine whether a patient passes or fails a spontaneous breathing trial: objective criteria (abnormal arterial blood gas measurements) and subjective criteria (diaphoresis, evidence of increasing effort, tachycardia, agitation, anxiety).
Ideally, the demonstration of an improvement of OS should also remain the major trial objective whenever a new combination partner is being added to a standard backbone therapy regimen, although this can be challenging when multiple poststudy options are available.
In this trial, objective responses to paclitaxel were seen in only 4.4% of patients treated.
The pre-specified primary immunological trial objective was to evaluate induction of autologous WT1-specific T cell responses.
Moreover, journal editors say that if a trial's objectives were listed at the outset, they would know how to better assess an article that presented its results.
This includes, for example, an ID number, the trial objectives, eligibility criteria, the main outcome(s), recruitment targets and contact details for the main trial personnel.
All patients were duly informed of the trial objectives and signed an informed consent form.
If assessment of duration of protection is included in the trial objectives the design should consist only of a PCD follow up.
They also suggested that the research teams should hold more than a single information session to ensure that volunteers understand the trial objectives.
In addition, presentations were given by a research team member at relevant industry forums, to explain the trial objectives and protocol, and to answer any questions.
