Group sequential analysis of marked point processes: Plasma donation trials.

ABSTRACT: Plasma donation plays a critical role in modern medicine by providing lifesaving treatments for patients with a wide range of conditions like bleeding disorders, immune deficiencies, and infections. Evaluation of devices used to collect blood plasma from donors is essential to ensure donor safety. We consider the design of plasma donation trials when the goal is to assess the safety of a new device on the response to transfusions compared to the standard device. A unique feature is that the number of donations per donor varies substantially so some individuals contribute more information and others less. The sample size formula is derived to ensure power requirements are met when analyses are based on generalized estimating equations and robust variance estimation. Strategies for interim m

SUBMITTER: Li K 

PROVIDER: S-EPMC12365355 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature