Although Mendelian randomization techniques can involve fairly computationally intensive analyses, the fundamental principles that guide these study designs are straightforward and if understood ...

Group sequential designs, which allow early stopping for efficacy or futility, may benefit from balanced sample sizes at interim and final analyses. This requirement ...

From 2016 to 2021, the National Institutes of Health Stroke Trials Network funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke initiated ten multicenter ...

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it. Developing a clinical trial’s effective monitoring plan can be overwhelming. The FDA acknowledges ...

Ensuring patient safety is paramount in the development of new pharmaceutical products, which, while beneficial, can also pose potential risks. Traditional methods for analyzing safety data have been ...

A recent review of randomization methods used in large multicenter clinical trials within the National Institutes of Health Stroke Trials Network identified preservation of treatment allocation ...

The rdlocrand package implements estimation, inference, and graphical procedures for Regression Discontinuity (RD) designs using local randomization methods. Cattaneo, Frandsen and Titiunik (2015): ...