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Novel composite clinical endpoints and risk scores used in clinical trials in pulmonary arterial hypertension

Lookup NU author(s): Emeritus Professor Nick Europe-Finner

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 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.


Publication metadata

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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