We conducted a pre-trial analysis of potentials participants of the MORE CARE trial.
In pre-trial analysis, we calculated that when a type I error is limited to.05 (two-tailed test), a total of about 300 patients would need to be accrued to afford an 80% power to detect a 36% relative reduction in the mortality hazard rate of patients in the systematic lymphadenectomy (i.e., increasing the 5-year survival rate from 64 to 75%, which corresponds to a hazard ratio (HR) of 0.64).
Such information can be very valuable by informing trial design and pre-trial power analysis of future randomized controlled efficacy studies.
Sample size for the study was calculated from a pre-trial power analysis, based on the previously published primary clinical outcome DAS28 score.
Notably, the PHW intervention effect was found only in patients who initiated ART pre-trial in stratified analysis, i.e. the group on ART longest, suggesting that this intervention may be best suited for patients who have taken ART for longer periods and are prone to treatment fatigue and its consequences.
Additionally, intention-to-treat analysis and pre-trial sample size estimate were not applied.
Conducted legal research, writing and analysis of pending pre-trial motions, post-trial motions and evidentiary issues.
It will first set out the context in which the Milošević proceedings began, in order to provide a detailed analysis of the pre-trial phase and trial phase, before describing the final stages of the proceedings.
Subgroup analysis of patients starting ART pre-trial showed a trend toward improved outcomes (p = 0.076) but analysis of those starting ART during the trial was not significant (p = 0.30).
This paper describes the design and analysis of a prototype experiment for the pre-trial assessment of blinding in a drug trial.
Mean pre-trial and post-trial school score was used in the analysis to control for potential differences in baseline nutrition knowledge.
