Abstract P328: A Retro And Prospective Review Of Within Session Clinic Bp Assessment In Hypertenison Clinical Trials

Abstract

There has been an increased interest and discussion around oscillometric blood pressure variability across the use of different BP measurement modalities and technology. Recent publications have referenced the BP variability as Very short term, short term, mid term and long term variability with each variability associated with a specific BP modality. The scientific and medical working groups have referenced the importance of capturing replicate readings during a standard clinic assessment. An area which has not received as much focus is on the assessment of BP variability within a standard clinic assessment with replicate readings. This becomes of specific interest during the conduct of a clinical trial where BP assessment can be a primary efficacy endpoint (hypertension drug development) or safety (Draft FDA Pressor guidance). This abstract will approach this specific area by providing examples and analysis from recent clinical trials which incorporated standardized clinic BP technology and automated sequence of BP readings across the study population. Each of the studies implemented a different sequence of readings and visit averaging function which will also be expanded upon in the presentation as to developing industry and scientific guidelines. Through this abstract and presentation the attendee will be provided present approaches to clinic/office based assessment in clinical trials and decisions around implementation strategies to address observed variability.