The Acute Stroke Therapy by Inhibition of Neutrophils study – Key features and impact. (12th July 2022)

• Record Type: Journal Article
• Authors: Kirby, Simon; Chuang‐Stein, Christy
• Other Names: Senn Stephen guestEditor.; Smith Mike K. guestEditor.
• Is Part Of: Pharmaceutical statistics. Volume 21:Number 4(2022)
• Page Start: 720
• Page End: 728
• Publication Date: 2022-07-12
• Subjects: Bayesian design and analysis -- longitudinal model -- normal dynamic linear model -- real‐time dose decisions -- response adaptive design; Pharmacy -- Statistical methods -- Periodicals; Pharmacy -- Statistics -- Periodicals; 615.10727
• DOI: 10.1002/pst.2218
• Languages: English
• ISSNs: 1539-1604

Abstract

Abstract: The Acute Stroke Therapy by Inhibition of Neutrophils (ASTIN) study, initiated in November of the year 2000, is now widely recognized as having been a landmark study in the history of clinical trials. We look at why this is the case by considering its key features and impact. These key features are: the use of Bayesian design and analysis; the use of the normal dynamic linear model; the response adaptive nature of the study; the use of real‐time dosing decisions; and the use of an integrated model to predict 90‐day response on the Scandinavian Stroke Scale. Our overall conclusion is that the ASTIN study's main impact came from showing the clinical trial community the feasibility of the novel design and analysis used when most of these key features were rarely used in industry trials, let alone used together in one trial in a disease area with a tremendous unmet medical need.