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All Outputs (3)

Central adjudication of serious events did not affect trial's safety results: data from the Efficacy of Nitric Acid in Stroke (ENOS trial) (2018)
Journal Article
Godolphin, P., Montgomery, A., Woodhouse, L., Bereczki, D., Berge, E., Collins, R., …ENOS Investigators. (2018). Central adjudication of serious events did not affect trial's safety results: data from the Efficacy of Nitric Acid in Stroke (ENOS trial). PLoS ONE, 13(11), Article e0208142. https://doi.org/10.1371/journal.pone.0208142

Background and Purpose: Central adjudication of serious adverse events (SAEs) can be undertaken in clinical trials, especially for open-label studies where outcome assessment may be at risk of bias. This study explored the effect of central adjudicat... Read More about Central adjudication of serious events did not affect trial's safety results: data from the Efficacy of Nitric Acid in Stroke (ENOS trial).

Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: secondary analysis and simulation (2018)
Journal Article
Godolphin, P., Hepburn, T., Sprigg, N., Walker, L., Berge, E., Collins, R., …Montgomery, A. (2018). Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: secondary analysis and simulation. Contemporary Clinical Trials Communications, 12, 176-181. https://doi.org/10.1016/j.conctc.2018.11.002

Background Central adjudication of stroke type is commonly implemented in large multicentre clinical trials. We investigated the effect of central adjudication of diagnosis of stroke type at trial entry in the Efficacy of Nitric Oxide in Stroke (E... Read More about Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: secondary analysis and simulation.

Robust assessment of two-treatment higher-order cross-over designs against missing values (2018)
Journal Article
Godolphin, P., & Godolphin, E. (2019). Robust assessment of two-treatment higher-order cross-over designs against missing values. Computational Statistics and Data Analysis, 132, 31-45. https://doi.org/10.1016/j.csda.2018.06.020

© 2018 Elsevier B.V. In scientific experiments where human behaviour or animal response is intrinsically involved, such as clinical trials, there is a strong possibility of recording missing values. Missing data in a clinical trial has the potential... Read More about Robust assessment of two-treatment higher-order cross-over designs against missing values.