In the pediatric phase III comparator study, the difference between urinary free cortisol levels in patients treated with ciclesonide 80 mcg twice daily (+1.54 nmol/mmol creatinine) versus patients treated with fluticasone propionate 88 mcg twice daily (−1.83 nmol/mmol creatinine) was statistically significant (P=0.0062) (Pedersen et al. 2004b).
Comparative studies between a novel diagnostic intervention and a 'gold standard' reference comparator, such as those included in this assessment, can only demonstrate non-inferiority of the intervention.
This multicentre, randomized, open-label, parallel-arm, comparator study was undertaken in 36 centres in the UK between June 2006 and April 2008.
In the retrospective comparator study, there was no significant difference in 30-day mortality between groups.
The key weakness was selection of a single comparator study.
The comparator study did not report this outcome [ 20].
RA patients appropriate for clinical trials are increasingly difficult to recruit, and the switch to active comparator study designs has increased the number of patients and the observation time required to discriminate reliably the differences in change between treatment arms.
Comparator: studies comparing chest X-ray with chest ultrasound.
All study types were included (RCTs, non-RCTs, prospective comparator studies, retrospective comparator studies, prospective and retrospective noncomparator studies, and case reports).
As minister, I published an international comparators study by civil servants into drug policy, the first proper assessment of our drug laws for 43 years.
