Considerations for Endpoints in Lung Transplant Clinical Trials: An ISHLT Consensus Statement

Published 16 December 2025

John Greenland, MD, PhD; Michael Perch, MD; Kieran Halloran, MD, MSc; Deborah Levine, MD; Eric Morrell, MD, MA; Anna Reed, MBChB; Ciara Shaver, MD, PhD; Jonathan Singer, MD, MS; Stuart Sweet, MD, PhD; Robin Vos, MD, PhD; Shambhu Aryal, MD, FCCP; Nicholas Avdimiretz, MD, FRCPC; Fay Burrows, BPharm; Daniel Calabrese, MD; Fiorella Calabrese, MD; Silvia Campos, PhD; Michael Combs, MD, MS; Marc de Perrot, MD, MSc, FRCSC; Göran Dellgren, MD, PhD; Joshua Diamond, MD, MS; Thomas Egan, MD, MSc; Patricia Ging, MSc; David Glidden, PhD; Martin Goddard, MB BCh, FRCS, FRCPath; Soma Jyothula, MD; Michael Keller, MD; Hrishikesh Kulkarni, MD, MSCI; Johanna Kwakkel-van Erp, MD, PhD; Vibha Lama, MD, MS; Nandor Marczin, MD, PhD; Tereza Martinu, MD, MHS; Megan Neely, PhD; Scott Palmer, MD, MHS; Caroline Patterson, BMBS, MD; Elizabeth N. Pavlisko, MD; Christine Pham, PharmD; Melissa Sanchez, PsyD, MSc; Hans Henrik Schultz, MD, PhD; Nicolaus Schwerk, MD, PhD; Unmil Shah, MD; Michael Shashaty, MD, MSCE; Lianne Singer, MD; Patrick Smith, PhD, MPH; Laurie Snyder, MD, MHS; Melinda Solomon, MD, MSc; Stijn Verleden, PhD; Veronique Verplancke, MD; Adriana Zeevi, PhD, ABHI; Jamie Todd, MD, MHS

J Heart Lung Transplant. December 2025.

• Advanced Lung Failure & Transplantation
• Consensus Document
• Publications & Journals
• Research & Immunology
• Standards & Guidelines

Clinical Trials are the cornerstone of an evidence-based approach to improve lung transplant outcomes. However, barriers to clinical trials in this field include a lack of clarity as to the value of specific clinical trial endpoints, the time needed to reach some endpoints, and the complexities in how trials should be structured given the heterogeneity and small size of the lung transplantation population.

To address this challenge, a multidisciplinary working group of 49 experts from ISHLT developed this consensus statement to present 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. 

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.

Read at JHLT