@article{Greenland:2026:10.1016/j.healun.2025.09.017,
author = {Greenland, JR and Perch, M and Halloran, K and Levine, DJ and Morrell, ED and Reed, A and Shaver, CM and Singer, JP and Sweet, SC and Vos, R and Aryal, S and Avdimiretz, N and Burrows, F and Calabrese, D and Calabrese, F and Campos, S and Combs, M and de, Perrot M and Dellgren, G and Diamond, JM and Egan, T and Ging, P and Glidden, DV and Goddard, M and Jyothula, S and Keller, M and Kulkarni, H and Kwakkel-van, Erp JM and Lama, V and Marczin, N and Martinu, T and Neely, ML and Palmer, SM and Patterson, CM and Pavlisko, EN and Pham, C and Sanchez, M and Schultz, HHL and Schwerk, N and Shah, U and Shashaty, M and Singer, L and Smith, P and Snyder, LD and Solomon, M and Verleden, S and Verplancke, V and Zeevi, A and Todd, JL},
doi = {10.1016/j.healun.2025.09.017},
journal = {J Heart Lung Transplant},
pages = {e104--e128},
title = {Considerations for Endpoints in Lung Transplant Clinical Trials: An ISHLT Consensus Statement.},
url = {http://dx.doi.org/10.1016/j.healun.2025.09.017},
volume = {45},
year = {2026}
}

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TY  - JOUR
AB  - Clinical trials in lung transplantation have been hindered by a lack of clarity on the formulation and significance of endpoints for evaluating therapeutic efficacy. To address this challenge, a multidisciplinary working group from the International Society for Heart and Lung Transplantation developed consensus recommendations on endpoints beyond mortality. These endpoints include primary graft dysfunction (PGD), chronic lung allograft dysfunction (CLAD), acute cellular rejection (ACR), antibody-mediated rejection (AMR), immunosuppression-related complications, patient-reported outcomes (PROs), and pediatric-specific considerations. For each endpoint, a subgroup reviewed measurement best practices, assessed links to clinical benefit, and evaluated the evidence supporting their utility in clinical trial settings. Consensus was established through a Delphi process involving three rounds of voting. 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 transplantation outcomes.
AU  - Greenland,JR
AU  - Perch,M
AU  - Halloran,K
AU  - Levine,DJ
AU  - Morrell,ED
AU  - Reed,A
AU  - Shaver,CM
AU  - Singer,JP
AU  - Sweet,SC
AU  - Vos,R
AU  - Aryal,S
AU  - Avdimiretz,N
AU  - Burrows,F
AU  - Calabrese,D
AU  - Calabrese,F
AU  - Campos,S
AU  - Combs,M
AU  - de,Perrot M
AU  - Dellgren,G
AU  - Diamond,JM
AU  - Egan,T
AU  - Ging,P
AU  - Glidden,DV
AU  - Goddard,M
AU  - Jyothula,S
AU  - Keller,M
AU  - Kulkarni,H
AU  - Kwakkel-van,Erp JM
AU  - Lama,V
AU  - Marczin,N
AU  - Martinu,T
AU  - Neely,ML
AU  - Palmer,SM
AU  - Patterson,CM
AU  - Pavlisko,EN
AU  - Pham,C
AU  - Sanchez,M
AU  - Schultz,HHL
AU  - Schwerk,N
AU  - Shah,U
AU  - Shashaty,M
AU  - Singer,L
AU  - Smith,P
AU  - Snyder,LD
AU  - Solomon,M
AU  - Verleden,S
AU  - Verplancke,V
AU  - Zeevi,A
AU  - Todd,JL
DO  - 10.1016/j.healun.2025.09.017
EP  - 128
PY  - 2026///
SP  - 104
TI  - Considerations for Endpoints in Lung Transplant Clinical Trials: An ISHLT Consensus Statement.
T2  - J Heart Lung Transplant
UR  - http://dx.doi.org/10.1016/j.healun.2025.09.017
UR  - https://www.ncbi.nlm.nih.gov/pubmed/41400593
VL  - 45
ER  - 

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