Cross-over trials in clinical research pdf

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Ruaro 1,3 , T. Schaefer 1,3 , M. Walcher 1,3 , O. Bukstein 4 and F. Systematic reviews of treatment interventions in stable or chronic conditions often require the synthesis of clinical trials with a cross-over design. Previous work has indicated that methodology for analysing cross-over data is inadequate in trial reports and in systematic reviews assessing trials with this design.

We assessed systematic review methodology for synthesising cross-over trials among Cochrane Cystic Fibrosis and Genetic Disorders Group reviews published to July , and assessed the quality of reporting among the cross-over trials included in these reviews. We performed data extraction of methodology and reporting in reviews, trials identified and trials included within reviews. We reviewed a total of Cochrane systematic reviews including 53 reviews which synthesised evidence from cross-over trials.

Despite development of accessible, technical guidance and training for Cochrane systematic reviewers, statistical analysis and reporting of cross-over data is inadequate at both the systematic review and the trial level. Download Product Flyer. This is a dummy description. Statistics Applied to Clinical Trials pp Cite as.

The two-period crossover trial has the evident advantage that by the use of within-patients comparisons, the usually larger between-patient variability is not used as a measuring stick to compare treatments. However, a prerequisite is that the order of the treatments does not substantially influence the outcome of the treatment.