Fabian Falck, Xuan Zhu, Sahra Ghalebikesabi, Matthias Kormaksson, Marc Vandemeulebroecke, Cong Zhang, Ruvie Martin, Stephen Gardiner, Chun Hei Kwok, Dominique M West, Luis Santos, Chengeng Tian, Yu Pang, Aimee Readie, Gregory Ligozio, Kunal K Gandhi, Tom Nichols, Ann-Marie Mallon, Luke Kelly, David Ohlssen, George Nicholson
OBJECTIVE: Clinical trials involve the collection of a wealth of data, comprising multiple diverse measurements performed at baseline and follow-up visits over the course of a trial. The most common primary analysis is restricted to a single, potentially composite endpoint at one time point. While such an analytical focus promotes simple and replicable conclusions, it does not necessarily fully capture the multi-faceted effects of a drug in a complex disease setting. Therefore, to complement existing approaches, we set out here to design a longitudinal multivariate analytical framework that accepts as input an entire clinical trial database, comprising all measurements, patients, and time points across multiple trials...
April 18, 2024: Journal of Biomedical Informatics