June 28, 2021 - Publications Update - The Study's Design
PrecISE researchers published two articles to share how the study's design works. The articles are detailed below. As they planned the PrecISE study, researchers made many key decisions. For example, they decided how to make PrecISE different from other studies, the benefits of the design for studying severe asthma, and what participants will do in the study. The goal of these articles is to explain how those decisions were made. Sharing information like this can help other researchers.
See more below.
"The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations"
Published in the Journal of Biopharmaceutical Statistics
This article outlines the plan for how people doing research in PrecISE will collect and examine study data. The way study participants will be assigned to different treatment groups is explained. The timing of when and how researchers will use data is also outlined. The authors share many other key data-related elements from the design of PrecISE.
"PrecISE: Precision Medicine in Severe Asthma: An adaptive platform trial with biomarker ascertainment"
Published in the Journal of Allergy and Clinical Immunology
The goals of PrecISE are explained in this article. The authors explain how different treatments, or therapies, were added to the study design. Patient groupings based on profiles, using "biomarkers," is a major focus on this article.