In the information age, bridging the gap between data and clinical application is crucial. The Center for Clinical and Translational Science (CCTS) is making significant investments in this area. Over ...

WASHINGTON – Sponsors who want to use wearable devices in clinical trials should pay special attention to issues such as ensuring the clinical trials are blinded, data integrity, and whether the ...

A new guideline released by the European Medicines Agency (EMA) on 23 January updates the agency's thinking on the statistical principles to be considered while investigating veterinary pharmaceutical ...

The goal of this paper is to provide guidelines for appropriate questions that should be considered early in the design stage to facilitate the interactions between clinical and statistical teams and ...

Statistical fragility refers to the vulnerability of clinical trial results to minor changes in event outcomes. The fragility index quantifies this vulnerability by determining the minimum number of ...

How did you get into statistics and biometrics in biotech? I went to graduate school for biology initially. When I first joined the industry as a biostatistician with Allergan 14 years ago, there was ...