New ISHLT Document on Considerations for Endpoints in Lung Transplant Clinical Trials
A new ISHLT Document, Considerations for Endpoints in Lung Transplant Clinical Trials: An ISHLT Consensus Statement, has been published in JHLT and is available to read online!
Led by John Greenland, Jamie Todd and Michael Perch, this document provides practical guidance for operationalizing these endpoints and outlines their optimal use in clinical trials. By standardizing trial design, these recommendations aim to accelerate the development of urgently needed therapies to improve lung transplant outcomes.
Developed by a multidisciplinary working group of 49 experts from ISHLT, this consensus statement presents expert opinions on the considerations and definitions for endpoints, which may be targeted in clinical trials of novel interventions aimed at improving lung recipient outcomes. For each included endpoint, the document describes the relationship of the endpoint to mortality or other clinically meaningful longer-term outcomes and gives recommendations on the approach to measure, operationalize, and, if applicable, adjudicate these conditions when used as trial endpoints.
Visit the Standards & Guidelines page for details, top takeaways, and links to read or download the document.