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Lookup NU author(s): Emeritus Professor Nick Europe-Finner
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© The Author(s) 2020.This manuscript on endpoints incorporates the broad experience of members of Pulmonary Vascular Research Institute’s Innovative Drug Development Initiative as an open debate platform for academia, the pharmaceutical industry and regulatory experts surrounding the future design of clinical trials in pulmonary hypertension. It reviews our current understanding of endpoints used in phase 2 and 3 trials for pulmonary hypertension and discusses in detail the value of newer approaches. These include the roles of composite endpoints and how these can be developed and validated. The newer concept of risk analysis is also discussed, including how such risk scores might be utilised as endpoints in clinical trials.
Author(s): Sitbon O, Nikkho S, Benza R, Deng C, W Farber H, G Maitland M, Hassoun P, Meier C, Pepke-Zaba J, Prasad K, Seeger W, Corris PA
Publication type: Article
Publication status: Published
Journal: Pulmonary Circulation
Year: 2020
Volume: 10
Issue: 4
Online publication date: 07/10/2020
Acceptance date: 11/09/2020
Date deposited: 18/01/2021
ISSN (print): 2045-8932
ISSN (electronic): 2045-8940
Publisher: SAGE Publications Ltd
URL: https://doi.org/10.1177/2045894020962960
DOI: 10.1177/2045894020962960
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