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Oliver Langford

Publications and source records attributed to Oliver Langford.

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Alzheimer's Clinical Research Data via R Packages: the alzverse

Sharing clinical research data is essential for advancing research in Alzheimer's disease (AD) and other therapeutic areas. However, challenges in data accessibility, standardization, documentation, usability, and reproducibility continue to impede this goal. In this article, we highlight the advantages of using R packages to overcome these challenges using two examples. The A4LEARN R package includes data from a randomized trial (the Anti-Amyloid Treatment in Asymptomatic Alzheimer's [A4] study) and its companion observational study of biomarker negative individuals (the Longitudinal Evaluation of Amyloid Risk and Neurodegeneration [LEARN] study). The ADNIMERGE2 R package includes data from the Alzheimer's Disease Neuroimaging Initiative (ADNI), a longitudinal observational biomarker and imaging study. These packages collect data, documentation, and reproducible analysis vignettes into a portable bundle that can be installed and browsed within commonly used R programming environments. We also introduce the alzverse package which leverages a common data standard to combine study-specific data packages to facilitate meta-analyses. By promoting collaboration, transparency, and reproducibility, R data packages can play a vital role in accelerating clinical research.

stat.CO

A critical evaluation of longitudinal proportional effect models

Nonlinear longitudinal proportional effect models have been proposed to improve power and provide direct estimates of the proportional treatment effect in randomized clinical trials. These models assume a fixed proportional treatment effect over time, which can lead to bias and Type I error inflation when the assumption is violated. Even when the proportional effect assumption holds, these models are biased, and their inference is sensitive to the labeling of treatment groups. Typically, this bias favors the active group, inflates Type I error, and can result in one-sided testing. Conversely, the bias can make it more difficult to detect treatment harm, creating a safety concern.

stat.ME