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In light of the large numbers of variables intrinsic to biomarker studies, validation of preliminary data for clinical implementation presents a significant challenge and may only be realized with large trials that involve significant patient numbers.
This is consistent with our findings that small studies had lower methodological quality compared with large trials.
These interventions principally involve collaborative care management treatments with large trials reporting impressive treatment effects [ 14- 17].
Thus, small trials in critical care medicine are of limited quality in design compared with large trials.
N-of-1 study design maintains the methodological safeguards provided by RCTs (blinding, randomization and controls) yet avoids the disadvantages associated with large trials.
Furthermore, the small trials were of low quality in methodology compared with large trials, which may partly account for the small-study effects.
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Small sample size may overestimate the efficacy of nefopam in the prevention of shivering compared with large trial.
AstraZeneca is applying for approval based on Phase 2 trials, each with about 200 lung cancer patients who did not respond to other treatments, although it is also proceeding with larger trials.
In comparison with larger trials done in the adult population, relatively few pediatric subjects will be studied.
The crossover rate from epidural to IV analgesia in our study (14.3%) was in keeping with rates reported in recent RCTs, which have ranged from 6.5% to 19.4% with larger trials reporting lower rates of crossover (Table 9) [22], [30], [30].
It is hoped that with larger trials, one can fully determine the relationship between telemonitoring and hospice enrollment.
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