Open AccessUpdating Clinical Endpoint Definitions
Author(s) -
Hassoun Paul M.,
Nikkho Sylvia,
Rosenzweig Erika B.,
Moreschi Gail,
Lawrence John,
Teeter John,
Meier Christian,
Ghofrani Ardeshir H.,
Minai Omar,
Rinaldi Paula,
Michelakis Evangelos,
Oudiz Ronald J
Publication year - 2013
Publication title -
pulmonary circulation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.791
H-Index - 40
ISSN - 2045-8940
DOI - 10.4103/2045-8932.109920
Subject(s) - medicine , clinical endpoint , clinical trial , endpoint determination , surrogate endpoint , intensive care medicine , medical physics
The 6‐Minute Walk Distance (6‐MWD) has been the most utilized endpoint for judging the efficacy of pulmonary arterial hypertension (PAH) therapy in clinical trials conducted over the past two decades. Despite its simplicity, widespread use in recent trials and overall prognostic value, the 6‐MWD has often been criticized over the past several years and pleas from several PAH experts have emerged from the literature to find alternative endpoints that would be more reliable in reflecting the pulmonary vascular resistance as well as cardiac status in PAH and their response to therapy. A meeting of PAH experts and representatives from regulatory agencies and pharmaceutical companies was convened in early 2012 to discuss the validity of current as well as emerging valuable endpoints. The current work represents the proceedings of the conference.